02/10/1998
|
Amerge
|
naratriptan
|
Migraine
|
Summary is pending
|
Labeling
|
|
|
|
R
|
Glaxo Wellcome
|
|
FALSE'
|
Antimigraine
|
10/15/1998
|
Versed
|
midazolam
|
Sedation/anxiolysis/ amnesia
|
Specified the effective dose, effective dose range, and time of onset Defined volume of distribution and similarity to adult protein binding and elimination Additional information on AE's and warnings about concomitant medications Identified a subpopulation (children with congenital heart disease and pulmonary hypertension) at higher risk for AE's and the need to start therapy at the lower end of the dosing range
|
Labeling
|
B
|
|
|
|
Roche
|
09/18/1998
|
FALSE'
|
Hypnotic
|
12/17/1998
|
Ziagen
|
abacavir
|
HIV infection
|
Labeling for 3 months - 12 years Information on dose, efficacy, PK parameters and AE profile
|
Labeling
|
B
|
|
|
|
GlaxoSmithKline
|
12/14/1998
|
FALSE'
|
Antiviral
|
04/15/1999
|
Motrin
|
ibuprofen
|
Fever, minor aches & pain, cold symptoms
|
Extended age range from 2 years to 6 months for the over-the-counter use based on a large safety database (27,000 patients)
|
Labeling
|
B
|
|
|
|
McNeil
|
07/01/1998
|
FALSE'
|
Analgesic; Antipyretic
|
06/17/1999
|
Cutivate Cream
|
fluticasone propionate
|
Treatment of corticosteroid responsive dermatoses
|
Extended the age range from 5 years down to 3 months of age
|
Labeling
|
|
|
|
R
|
Elan
|
|
FALSE'
|
Anti-inflammatory, topical
|
07/02/1999
|
Zaditor Ophthalmic Soln.
|
ketotifen fumarate
|
Allergic conjunctivitis
|
Approved down to 3 years of age; efficacy extrapolated from adult data
|
Labeling
|
|
|
|
R
|
Novartis
|
|
FALSE'
|
Antihistamine, topical
|
07/09/1999
|
Tagamet HB 200 Liquid OTC
|
cimetidine
|
Heartburn and indigestion
|
New indication approved down to 12 years of age; new OTC suspension
|
Labeling
|
|
|
|
R
|
GlaxoSmithKline
|
|
FALSE'
|
Antiulcerative
|
07/14/1999
|
Omnicef
|
cefdinir
|
Otitis media
|
Approved 5-day treatment regimen; previously labeled for a 5-10 day treatment regimen
|
Labeling
|
|
|
|
R
|
Abbott
|
|
FALSE'
|
Antibiotic
|
07/23/1999
|
Topamax Tablets
|
topiramate
|
Adjunctive treatment of partial onset seizures and generalized tonic clonic seizures
|
Approved down to 2 years of age
|
Labeling
|
|
|
|
R
|
Ortho-McNeil
|
|
FALSE'
|
Anticonvulsant
|
07/26/1999
|
Relenza Rotadisk
|
zanamivir
|
Treatment of influenza A and B
|
New indication approved down to 12 years of age
|
Labeling
|
|
|
|
R
|
GlaxoSmithKline
|
|
FALSE'
|
Antiviral
|
08/18/1999
|
Derma-Smoothe/FS Topical Oil
|
fluocinolone
|
Atopic dermatitis
|
Approved down to 6 years of age; previously approved in adults only
|
Labeling
|
|
|
|
R
|
Hill
|
|
FALSE'
|
Anti-inflammatory, topical
|
08/24/1999
|
Ceftin Oral Suspension
|
cefuroxime
|
Acute bacterial sinusitis
|
Approved down to 3 years of age
|
|
|
|
|
R
|
Lifecycle Ventures
|
|
TRUE'
|
Antibiotic
|
09/17/1999
|
Accolate Tablets
|
zafirlukast
|
Prophylaxis and chronic treatment of asthma
|
Approved down to 7 years of age; efficacy extrapolated from demonstrated efficacy in patients 15 years and older
|
Labeling
|
|
|
|
R
|
AstraZeneca
|
|
FALSE'
|
Antiasthmatic
|
09/24/1999
|
Alamast
|
pemirolast
|
Allergic Conjunctivitis
|
Safety and effectiveness established down to 3 years
|
Labeling
|
B
|
|
|
|
Santen
|
08/11/1999
|
FALSE'
|
Antihistamine, topical
|
10/22/1999
|
Zantac
|
ranitidine
|
Gastroesophageal Reflux
|
Small studies in newborns 0 to 1 month receiving ECMO did not demonstrate efficacy but provided information on dose and PK
|
Labeling
|
B
|
|
|
|
Glaxo
|
01/19/1999
|
FALSE'
|
Antiulcerative
|
11/08/1999
|
Omnicef
|
cefdinir
|
Bronchitis
|
Approved for use in adolescents
|
Labeling
|
|
|
|
R
|
Abbott
|
|
FALSE'
|
Antibiotic
|
12/08/1999
|
Alocril
|
nedocromil
|
Allergic Conjunctivitis
|
Approved down to 3 years of age
|
Labeling
|
|
|
|
R
|
Allergan
|
|
FALSE'
|
Antihistamine, topical
|
01/12/2000
|
Advil
|
ibuprofen
|
Fever, minor aches & pain, cold symptoms
|
Extended age range from 2 years to 6 months for the over-the-counter use based on a large safety database (14,291 patients)
|
Labeling
|
B
|
|
|
|
Whitehall
|
07/01/1998
|
FALSE'
|
Analgesic; Antipyretic
|
02/04/2000
|
Tri-Nasal Spray
|
triamcinolone
|
Allergic rhinitis
|
Approved down to 12 years of age
|
Labeling
|
|
|
|
R
|
Muro
|
|
FALSE'
|
Anti-inflammatory, topical
|
03/17/2000
|
Lamisil AT Spray Pump
|
terbinafine
|
Jock itch, athletes foot, ringworm
|
Approved for OTC use
|
Labeling
|
|
|
|
R
|
Novartis
|
|
FALSE'
|
Antifungal, topical
|
04/04/2000
|
Humalog Injection
|
insulin lispro
|
Type 1 diabetes
|
Approved for use in the pediatric population; instructions on use of the diluted product in the pediatric population
|
Labeling
|
|
|
|
R
|
Lilly
|
|
FALSE'
|
Antidiabetic
|
04/12/2000
|
Trivagizole 3 Vaginal Cream
|
clotrimazole
|
Vaginal yeast infection
|
Approved for OTC use in patients 12 years of age and older
|
Labeling
|
|
|
|
R
|
Taro
|
|
FALSE'
|
Antifungal, topical
|
04/20/2000
|
Lantus
|
insulin glargine
|
Type 1 Diabetes
|
Safety and effectiveness established down to 6 years
|
Labeling
|
B
|
|
|
|
Aventis
|
07/12/1999
|
FALSE'
|
Antidiabetic
|
04/26/2000
|
Relenza Rotadisk
|
zanamivir
|
Treatment of Influenza A and B
|
Approved down to 7 years of age
|
Labeling
|
|
|
|
R
|
GlaxoSmithKline
|
|
FALSE'
|
Antiviral
|
05/22/2000
|
Optivar
|
azelastine
|
Itching associated with Allergic Conjunctivitis
|
Safety and effectiveness established down to 3 years
|
Labeling
|
B
|
|
|
|
Muro Pharma/Asta Medica
|
08/11/1999
|
FALSE'
|
Antihistamine, topical
|
05/26/2000
|
Differin Cream
|
adapalene
|
Acne vulgaris
|
Approved down to 12 years of age
|
Labeling
|
|
|
|
R
|
Galderma
|
|
FALSE'
|
Antiacne, topical
|
06/16/2000
|
AmBisome Injection
|
amphotericin B
|
Cryptococcal meningitis in HIV infected patients
|
New indication approved down to 1 year of age; established a dose of 6mg/kg/day
|
Labeling
|
|
|
|
R
|
Fujisawa
|
|
FALSE'
|
Infectious disease (non-viral)
|
07/14/2000
|
ChloraPrep OneStep OTC
|
chlorhexidine/ isopropyl alcohol
|
Skin preparation prior to surgery
|
New indication approved down to 2 months of age; Warning: do not use in less than 2 months of age
|
|
|
|
|
R
|
Medi-Flex Hospital Products
|
|
FALSE'
|
Antiseptic
|
07/14/2000
|
Malarone
|
atovaquone/ proguanil
|
Treatment of malaria
|
Safety and efficacy for treatment of malaria established down to5 kg. Attributable AE occurring in e 5% of the pediatric patients (5-< 11 kg) was diarrhea (6%) Malarone tablets may be crushed and mixed with condensed milk just prior to administration for children who may have difficulty swallowing. The apparent clearance (CL/F) of both atovaquone and proguanil are related to body weight
|
Labeling
|
B
|
|
|
|
Glaxo Wellcome
|
08/06/2003
|
FALSE'
|
Antimalarial
|
07/27/2000
|
Vaniqa Cream
|
eflornithine
|
Reduction of facial hair in females
|
Approved for female patients down to 12 years of age
|
Labeling
|
|
|
|
R
|
Bristol-Myers Squibb
|
|
FALSE'
|
Hair removal
|
08/01/2000
|
Motrin Suspension
|
ibuprofen/ pseudoephedrine
|
Temporary relief of nasal and sinus congestion, minor body aches and pains, fever, stuffy nose, headache and sore throat
|
Information on the over-the-counter use in pediatric patients 2 to 11 years of age
|
Labeling
|
B
|
|
|
|
McNeil
|
|
FALSE'
|
Decongestant; anti-inflammatory
|
08/01/2000
|
Concerta Extended Release Tablets
|
methylphenidate
|
ADHD
|
Efficacy established down to 6 years of age
|
Labeling
|
|
|
|
R
|
Alza
|
|
FALSE'
|
CNS Stimulant
|
08/11/2000
|
Lodine XL
|
etodolac
|
Relief of signs & symptoms of Juvenile Rheumatoid Arthritis
|
New indication in 6 years -16 years Higher dose (per kg basis) in younger children which is approximately 2 times the lower dose recommended for adults
|
Labeling
|
B
|
|
|
|
Wyeth Ayerst
|
12/06/1999
|
FALSE'
|
Anti-inflammatory
|
08/21/2000
|
Unithroid Tablets
|
levothyroxine
|
Hypothyroidism
|
Approved down to the newborn
|
Labeling
|
|
|
|
R
|
Jerome Stevens
|
|
FALSE'
|
Thyroid replacement
|
08/24/2000
|
Advair Diskus
|
fluticasone/ salmeterol
|
Asthma
|
Approved down to 12 years of age
|
Labeling
|
|
|
|
R
|
GlaxoSmithKline
|
|
FALSE'
|
Antiasthmatic
|
08/25/2000
|
Lac-Hydrin
|
ammonium lactate
|
Xerosis, ichthyosis
|
Safety and effectiveness established in patients 2 11 years of age; previously approved ³12 years of age
|
Labeling
|
B
|
|
|
|
Westwood-Squibb
|
10/01/1999
|
FALSE'
|
Moisturizer
|
09/15/2000
|
QVAR
|
beclomethasone dipropionate
|
Maintenance treatment of asthma as prophylactic thrapy for asthma patients who require systemic corticosteroid administration
|
Summary is pending
|
Labeling
|
|
P
|
|
|
3M Health
|
|
FALSE'
|
Antiasthmatic
|
09/28/2000
|
Luvox
|
fluvoxamine
|
Treatment of obsessions and compulsions in patients with OCD
|
Determined that a dose adjustment (increased dose) may be necessary in adolescents and girls 8-11 years of age may require lower doses FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluvoxamine or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Fluvoxamine is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials The efficacy of fluvoxamine for the treatment of OCD was demonstrated in a 10-week multicenter placebo controlled study with 120 outpatients ages 8 to 17. In addition, 99 of these outpatients continued open-label fluvoxamine treatment for up to another one to three years, equivalent to 94 patient years
|
Labeling
|
B
|
|
|
|
Solvay
|
01/03/2000
|
FALSE'
|
Antipsychotic
|
09/29/2000
|
Flovent Diskus Inhalation Powder
|
fluticasone
|
Asthma
|
Approved down to 4 years of age; new delivery system
|
Labeling
|
|
|
|
R
|
GlaxoSmithKline
|
|
FALSE'
|
Antiasthmatic
|
10/12/2000
|
Neurontin
|
gabapentin
|
Adjunctive therapy in the treatment of partial seizures
|
Safety and effectiveness established down to 3 years Neuropsychiatric AE's identified in 3-12 year olds Oral clearance normalized per body weight increased in children <5 years Higher doses of gabapentin required in children <5 years
|
Labeling
|
B
|
|
|
|
Parke-Davis
|
02/02/2000
|
FALSE'
|
Anticonvulsant
|
10/27/2000
|
Atrovent Nasal Spray
|
ipratropium
|
Rhinorrhea
|
Approved down to 5 years of age
|
|
|
|
|
R
|
Boehringer Ingelheim
|
|
FALSE'
|
Antihistamine
|
11/14/2000
|
Trizivir Tablets
|
abacavir, lamivudine, zidovudine
|
HIV
|
Approved in adults and adolescents weighing e 40kg
|
Labeling_Trizinir_Prntlbl.pdf">Labeling
|
|
|
|
R
|
GlaxoSmithKline
|
|
FALSE'
|
Antiviral
|
11/17/2000
|
Tamiflu Capsule
|
oseltamivir
|
Prophylaxis of influenza A and B
|
Approved for prophylactic use down to 13 years of age
|
Labeling
|
|
|
|
R
|
Roche
|
|
FALSE'
|
Antiviral
|
11/27/2000
|
Benzamycin Pak
|
erythromycin-benzoyl peroxide
|
Acne vulgaris
|
Approved down to 12 years of age
|
Labeling
|
|
|
|
R
|
Dermik Laboratories, Inc.
|
|
FALSE'
|
Antiacne, topical
|
11/27/2000
|
Clindagel
|
clindamycin topical gel
|
Acne vulgaris
|
Approved down to 12 years of age
|
Labeling
|
|
|
|
R
|
Target Research Associates
|
|
FALSE'
|
Antiacne, topical
|
12/04/2000
|
Claritin
|
loratadine
|
Allergic rhinitis/Urticaria
|
Labeling for 2 - 5 year olds including information on dose, PK parameters and AE profile PK parameter in 2-5 year olds given a 5mg dose was comparable to the 10mg dose in children 6 years to adolescence
|
Labeling
|
B
|
|
|
|
Schering
|
08/14/2000
|
FALSE'
|
Antihistamine
|
12/08/2000
|
Protopic Ointment
|
tacrolimus
|
Atopic dermatitis
|
Approved down to 2 years of age; lower dose of 0.03% twice daily recommended for patients 2-15 years of age
|
Labeling
|
|
|
|
R
|
Fujisawa
|
|
FALSE'
|
Immunomodulator
|
12/11/2000
|
Maxalt and Maxalt-MLT
|
rizatriptan
|
Migraine
|
Summary is pending
|
|
|
|
|
R
|
Merck
|
|
FALSE'
|
Antimigraine
|
12/14/2000
|
TamiFlu
|
oseltamivir
|
Treatment of uncomplicated acute illness due to influenza
|
Safety and effectiveness established for treatment in patients 1-12 years of age The safety and effectiveness in pediatric patients younger than 1 year of age have not been established Safety and effectiveness for prophylaxis in pediatric patients younger than 13 years of age have not been established (Note: labeled for prophylaxis down to 1 year due to PREA on 12/21/2005) The adverse event profile in adolescents is similar to that for adults and pediatric patients aged 1 to 12 years Information on dosing, PK parameters, AE profile, and clinical studies
|
Labeling
|
B
|
|
|
|
Roche
|
03/22/2004
|
FALSE'
|
Antiviral
|
12/15/2000
|
Glucophage (immediate release)
|
metformin
|
Diabetes Mellitus
|
Safety and effectiveness as monotherapy established in patients 10-16 years of age
|
Labeling
|
B
|
|
|
|
Bristol-Myers Squibb
|
03/15/2000
|
FALSE'
|
Antidiabetic
|
12/20/2000
|
CellCept
|
mycophenylate
|
Prophylaxis of organ rejection in renal transplant patients
|
Approved for use down to 3 months of age as a combination regimen with cyclosporine and corticosteroids
|
Labeling
|
|
|
|
R
|
Hoffman- LaRoche
|
|
FALSE'
|
Immunosuppressant
|
12/21/2000
|
Benzaclin
|
benzoyl peroxide; clindamycin phosphate
|
Acne vulgaris
|
Approved down to 12 years of age
|
Labeling
|
|
|
|
R
|
Sanofi Aventis
|
|
FALSE'
|
Antiacne, topical
|
02/13/2001
|
Vasotec
|
enalapril
|
Hypertension
|
Labeling for 1 month-16 years of age Information on dose, efficacy and pharmacokinetics Information on preparation of a suspension
|
Labeling
|
B
|
|
|
|
Merck
|
02/02/2000
|
FALSE'
|
Antihypertensive
|
02/21/2001
|
Infuvite Pediatric
|
multivitamin infusion
|
Daily multivitamin maintenance
|
Approved for infants down to newborn
|
Labeling
|
|
|
|
R
|
Sabex, Inc.
|
|
FALSE'
|
Vitamin
|
02/23/2001
|
Diprivan
|
propofol
|
Induction and/or maintenance of anesthesia
|
Maintenance of anesthesia- age decreased down to 2 months from 3 years Induction of anesthesia remains the same- 3 years of age and above Concomitant administration with fentanyl may result in serious bradycardia Abrupt discontinuation following prolonged infusion may result in flushing of hands and feet, agitation, tremulousness and hyperirritability Propofol is not indicated for pediatric ICU sedation as safety has not been established. In a single multicenter trial of ICU sedation in critically ill pediatric patients (patients with upper respiratory tract infections excluded), the incidence of mortality (causality not established) was 9% in the propofol arm versus 4% in the standard sedative agents arm
|
Labeling
|
B
|
|
|
|
AstraZeneca
|
08/11/1999
|
FALSE'
|
Anesthetic agent
|
03/27/2001
|
Nasalcrom
|
cromolyn
|
Prevention and relief of nasal symptoms of hay fever and other nasal allergies
|
Established proper dose in 2 year - 6 year olds and provided additional safety and compliance data for this age group
|
Labeling
|
B
|
|
|
|
Pharmacia & Upjohn
|
11/02/1999
|
FALSE'
|
Antiasthmatic
|
03/30/2001
|
Ultane
|
sevoflurane
|
Induction and maintenance of general anesthesia
|
New study in pediatric patients 9 days-12 years comparing sevoflurane and halothane Precautions section and Adverse Events During Post-Marketing subsection updated to add information on the rare cases of seizures that have been reported in pediatric patients in association with sevoflurane use. The majority of cases were in children and young adults, most of whom had no medical history of seizures Pediatric information consolidated into new Pediatric Use subsection
|
Labeling
|
B
|
|
|
|
Abbott
|
08/02/2000
|
FALSE'
|
Anesthetic agent
|
05/11/2001
|
Agenerase Capusles and Oral Solution
|
amprenavir
|
HIV
|
Approved for use in combination with other antiretroviral agents; new labeling provides information about the effects of drug-drug interaction
|
Labeling
|
|
|
|
R
|
GlaxoSmithKline
|
|
FALSE'
|
Antiviral
|
06/06/2001
|
Mentax Cream
|
butenafine
|
Tinea versicolor
|
Approved down to 12 years of age; previously approved in adults only
|
Labeling
|
|
|
|
R
|
Bertek
|
|
FALSE'
|
Antifungal, topical
|
06/25/2001
|
Valtrex Caplets
|
valacyclovir
|
Treatment of cold sores
|
New indication approved for use down to 12 years of age
|
Labeling
|
|
|
|
R
|
GlaxoSmithKline
|
|
FALSE'
|
Antiviral
|
07/19/2001
|
Buspar
|
buspirone
|
General Anxiety Disorder
|
Safety and effectiveness were not established in patients 6 to 17 years of age for treatment of General Anxiety Disorder at doses recommended for use in adults PK parameters (AUC and Cmax) of buspirone and its active metabolite were found to be equal to or higher in children and adolescents than that of adults
|
Labeling
|
B
|
|
|
|
Bristol-Myers Squibb
|
05/22/2000
|
FALSE'
|
Antianxiety
|
08/16/2001
|
Epivir-HBV
|
lamivudine
|
Treatment of Chronic Hepatitis B
|
Safety and effectiveness established down to 2 years Established a dose of 3mg/kg/day up to a maximum of 100mg/day (adult dose)
|
Labeling
|
B
|
|
|
|
GlaxoSmithKline
|
07/25/2001
|
FALSE'
|
Antiviral
|
08/28/2001
|
Topamax Tablets and Sprinkle Capsules
|
topiramate
|
Seizures associated with Lennox-Gastaut syndrome
|
Approved for treatment down to 2 years of age
|
Labeling
|
|
|
|
R
|
R.W. Johnson
|
|
FALSE'
|
Anticonvulsant
|
10/01/2001
|
Betapace
|
sotalol
|
Arrhythmia
|
Analysis of 2 trials provided information on PK and PD in children 3 days 12 years; safety and efficacy have not been established Information on dose, pharmacokinetics and AE's Pharmacokinetics: BSA most important covariate and more relevant than age Smaller children (BSA < 0.33 m2) showed tendency for larger change in QTc and increased frequency of prolongation of the QTc interval as well as greater beta-blocking effects Individualized dosing on a mg/m2 basis Information on preparation of a suspension
|
Labeling
|
B
|
|
|
|
Berlex
|
01/06/2000
|
FALSE'
|
Antiarrhythmic
|
10/03/2001
|
Diprolene AF, Diprosone, Lotrisone
|
betamethason;betamethasone/ clotrimazole
|
Diprolene AF and Diprosone - Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses Lotrisone- Treatment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis
|
Diprolene AF Cream In an open-label study for the treatment of atopic dermatitis, 19 of 60 (32%) evaluable patients (ages 3 mo-12 years) showed HPA axis suppression. The younger the age group, the greater the proportion of patients with adrenal suppression. Indicated in patients 13 years and older. Not recommended in pediatric patients 12 years and younger Strengthened labeling in Clinical Pharmacology, Precautions- General and Pediatric Use subsections Local adverse reactions including signs of skin atrophy (telengiectasia, bruising, shininess) occurred in 10% of pediatric patients (3mo-12 years) Diprosone Cream, Ointment, Lotion A separate open-label study was performed in pediatric patients with atopic dermatitis for each Diprosone formulation Testing for HPA axis suppression was positive with each formulation in the age groups studied: Cream - 23% (ages 2yr-12yr); Ointment - 28% (ages 6mo-12yr); and Lotion - 73% (ages 6yr-12yr) Indicated in patients 13 years and older. Not recommended in pediatric patients 12 years and younger Strengthened labeling in Clinical Pharmacology, Precautions- General and Pediatric Use subsections Local adverse reactions including signs of skin atrophy (telengiectasia, bruising, shininess) occurred in the cream and ointment studies Lotrisone Not recommended for patients under the age of 17 years and not recommended for diaper dermatitis; previously not recommended for patients under the age of 12 years In an open-label study of Lotrisone cream for the treatment of tinea pedis, 17 of 43 (39.5%) evaluable patients (ages 12-16 years) demonstrated adrenal suppression as determined by cosyntropin testing In an open-label study of Lotrisone cream for the treatment of tinea cruris, 8 of 17 (47.1%) evaluable patients (ages 12-16 years) demonstrated adrenal suppression by cosyntropin testing Indicated in patients 17 years and older
|
Labeling
|
B
|
|
|
|
Schering
|
|
FALSE'
|
Anti-inflammatory, topical
|
10/10/2001
|
Derma-Smoothe/FS Topical Oil
|
fluocinolone
|
Atopic dermatitis
|
Approved down to 2 years of age
|
Labeling
|
|
|
|
R
|
Hill
|
|
FALSE'
|
Anti-inflammatory, topical
|
11/13/2001
|
Focalin
|
dexmethylphenidate
|
Attention Deficit Hyperactivity Disorder
|
Pending
|
Labeling
|
|
|
|
R
|
Celgene
|
|
FALSE'
|
CNS Stimulant
|
11/16/2001
|
Calcijex
|
calcitriol
|
Management of hypocalcemia in patients undergoing chronic renal dialysis
|
The safety and effectiveness of calcitriol was examined in a double-blind placebo-controlled trial of 35 pediatric patients (13-18 years of age) with end-stage renal disease and on dialysis. The primary efficacy endpoint favored the calcitriol-treated versus the placebo-treated patients Transient hypercalcemia was seen in 1 of 16 calcitriol-treated patients; 6 of 16 (38%) calcitriol-treated patients and 2 of 19 (11%) placebo-treated patients had Ca x P >75
|
Labeling
|
B
|
|
|
|
Abbott
|
02/16/2001
|
FALSE'
|
Vitamin
|
12/13/2001
|
Elidel
|
pimecrolimus
|
Treatment of mild/moderate atopic dermatitis
|
Indicated for short-term and intermittent long-term therapy for mild to moderate atopic dermatitis in non-immunocompromised patients 2 years and older Not recommended for use in pediatric patients less than 2 years of age. Infants on Elidel Cream had an increased incidence of some adverse events compared to vehicle which included pyrexia, URI, nasopharyngitis, gastroenteritis, otitis media, and diarrhea.
|
Labeling
|
B
|
|
|
|
Novartis
|
09/24/2001
|
FALSE'
|
Immunomodulator
|
12/20/2001
|
Alphagan
|
brimonidine
|
Prevention of post-operative IOP elevations
|
Safety and effectiveness established down to 2 years Somnolence in patients 2 to 6 years (50-83%) versus patients 7 years of age or older (25%)
|
Labeling
|
B
|
|
|
|
Allergan
|
10/10/2001
|
FALSE'
|
Ophthalmologic hypotensive
|
12/21/2001
|
Clarinex Tablets
|
desloratadine
|
Seasonal allergic rhinitis
|
Approved down to 12 years of age
|
Labeling
|
|
|
|
R
|
Schering
|
|
FALSE'
|
Antihistamine
|
12/28/2001
|
Rebetron; Rebetrol
|
ribavirin/intron a; ribavirin
|
Chronic hepatitis C
|
Labeling for 3 years to 16 years There are no safety and efficacy data on treatment for longer than 48 weeks in pediatric patients Pharmacokinetic information on patients 5 to 16 years with chronic hepatitis C virus infection Increased incidence of suicidal ideation or attempts (2.4% versus 1%) among pediatric patients compared to adult patients Decrease in rate of linear growth (mean percentile assignment decrease of 9%) and in rate of weight gain (mean percentile assignment decrease of 13%) during 48 weeks of treatment; a general reversal was noted during the 24 week post treatment period Patients with viral genotype 1, had a lower response rate to combination therapy compared to patients with genotype non-1, 36% versus 81% In general, the adverse event profile in the pediatric population was similar to that observed in adults New oral suspension developed
|
Labeling
|
B
|
|
|
|
Schering
|
05/09/2001
|
FALSE'
|
Antiviral
|
01/25/2002
|
Daypro
|
oxaprozin
|
Relief of signs and symptoms of Juvenile Rheumatoid Arthritis
|
New indication in 6 years -16 years
|
Labeling
|
B
|
|
|
|
Searle
|
12/06/1999
|
FALSE'
|
Anti-inflammatory
|
01/30/2002
|
Xopenex Inhalation Solution
|
levalbuterol
|
Treatment and prevention of bronchspasm
|
Approved down to 6 years of age; recommended dose is 0.31mg TID for patients 6-11 years of age
|
Labeling
|
|
|
|
R
|
Sepracor
|
|
FALSE'
|
Antiasthmatic
|
02/08/2002
|
Clarinex Tablets
|
desloratadine
|
Relief of pruritis/hives in patients with chronic idiopathic urticaria
|
Approved down to 12 years of age
|
Labeling
|
|
|
|
R
|
Schering
|
|
FALSE'
|
Antihistamine
|
02/08/2002
|
Clarinex Tablets
|
desloratadine
|
Perennial allergic rhinitis
|
Approved down to 12 years of age
|
Labeling
|
|
|
|
R
|
Schering
|
|
FALSE'
|
Antihistamine
|
02/08/2002
|
Acular & Acular PF
|
ketorolac
|
Relief of ocular itching due to seasonal allergic rhinitis and postoperative inflammation after cataract extraction
|
Safety and effectiveness established down to 3 years; previously approved down to 12 years
|
Labeling
|
B
|
|
|
|
Allergan
|
09/06/2001
|
FALSE'
|
Anti-inflammatory
|
02/14/2002
|
Mevacor
|
lovastatin
|
Heterozygous Familial Hypercholesterolemia
|
New indication in adolescent boys and girls (at least one year post-menarche) 10-17 years of age
|
Labeling
|
B
|
|
|
|
Merck
|
07/17/2001
|
FALSE'
|
Antilipemic
|
03/29/2002
|
Zerit
|
stavudine
|
HIV infection
|
Safety and effectiveness established down to birth Established a dose for newborns from birth to 13 days
|
Labeling
|
B
|
|
|
|
Bristol-Myers Squibb
|
08/13/2001
|
FALSE'
|
Antiviral
|
04/01/2002
|
Videx
|
didanosine
|
HIV infection
|
Safety and effectiveness established down to 2 weeks
|
Labeling
|
B
|
|
|
|
Bristol-Myers Squibb
|
08/13/2001
|
FALSE'
|
Antiviral
|
04/18/2002
|
Advil Cold Suspension
|
ibuprofen/ pseudoephedrine
|
Temporary relief of nasal and sinus congestion, headache, stuffy nose, sore throat, minor aches and pains, and fever
|
Information on the over-the-counter use in pediatric patients 2 to 11 years of age
|
Labeling
|
B
|
|
|
|
Whitehall
|
09/19/2001
|
FALSE'
|
Decongestant; anti-inflammatory
|
05/02/2002
|
Accutane
|
isotretinoin
|
Severe recalcitrant nodular acne
|
Safety and effectiveness information on pediatric patients 12-17 years of age Identified an increased incidence of back pain, arthralgia and myalgia in pediatric patients New General Precautions subsection- caution when prescribing Accutane to pediatric patients with disorders of bone metabolism, such as osteoporosis and osteomalacia Adolescents who participate in sports with a repetitive impact may be at increased risk for bone related injuries In an open-label study of pediatric patients (n=217) given a single course of therapy, 16 (7.9%) had decreases in lumbar spine bone mineral density (BMD) >4% (adjusted for body mass index); 21 (10.6%) patients had decreases in total hip BMD >5% (adjusted for body mass index)
|
Labeling
|
B
|
|
|
|
Hoffman La-Roche
|
06/12/2001
|
FALSE'
|
Antiacne
|
05/10/2002
|
QVAR
|
beclomethasone dipropionate
|
Maintenance treatment of asthma as prophylactic therapy
|
Summary is pending
|
|
|
P
|
|
|
3M Health
|
|
FALSE'
|
Antiasthmatic
|
06/05/2002
|
Ritalin LA Capsules
|
methylphenidate
|
Attention Deficit Hyperactivity Disorder
|
Approved for use in 6-12 years of age; once a day dose in the morning
|
Labeling
|
|
|
|
R
|
Novartis
|
|
FALSE'
|
CNS Stimulant
|
06/06/2002
|
Pepcid
|
famotidine
|
Gastroesophageal reflux
|
Labeling for patients less than 1 year of age including information on dose, PK/PD parameters and AE profile Lower dose recommended in patients <3 months of age Pediatric patients 0-3 months of age had clearance values 2 to 4-fold less than those in older patients and adults In a clinical study of 35 pediatric patients <1 year of age, agitation was observed in 5 patients on famotidine and resolved upon discontinuation of the drug
|
Labeling
|
B
|
|
|
|
Merck
|
11/21/2000
|
FALSE'
|
Antiulcerative
|
06/26/2002
|
Clarinex RediTabs Orally Disintegrating Tablets
|
desloratadine
|
Allergic rhinitis and chronic ideopathic urticaria
|
Approved for use down to 12 years of age; new formulation
|
Labeling
|
|
|
|
R
|
Schering
|
|
FALSE'
|
Antihistamine
|
07/12/2002
|
Prilosec
|
omeprazole
|
Gastroesophageal reflux and erosive esophagitis
|
Safety and effectiveness established in pediatric patients 2-16 years of age Information on dose, PK parameters, exposure/response and AE profile
|
Labeling
|
B
|
|
|
|
AstraZeneca
|
|
FALSE'
|
Antiulcerative
|
07/17/2002
|
Nasonex-nasal Elocon - topical
|
mometasone
|
Nasonex - Perennial and seasonal allergic rhinitis Elocon - Relief of inflammatory and pruritic manifestations of corticosteroid dermatose
|
Nasonex Nasal Spray Extended age range from 3 years down to 2 years In a clinical study in which pediatric patients 2-5 years were treated with mometasone nasal spray for up to 42 consecutive days, no significant effect on adrenal function was found Upper respiratory tract infection was more common with Nasonex (2/28) compared to placebo (0/28) Elocon Cream & Ointment Evidence of HPA axis suppression in pediatric patients 6-23 months of age Outlined local AE's as well as skin atrophy in pediatric patients 6-23 months of age Approved down to 2 years of age as in previous labeling Elocon Lotion Safety and effectiveness have not been established in pediatric patients below 12 years of age and use <12 year old is not recommended Should not be used for the treatment of diaper dermatitis
|
Labeling
|
B
|
|
|
|
Schering
|
11/07/2001
|
FALSE'
|
Anti-inflammatory, topical
|
07/26/2002
|
Singulair
|
montelukast
|
Prophylaxis and chronic treatment of asthma
|
Safety and effectiveness established in patients 12 months to 5 years of age Information on dose, PK parameters and AE profile in patients 12-23 months and 2-5 years New 4mg chewable tablet and 4mg oral granule formulations developed. The chewable tablets contain aspartame whereas the oral granule formulation does not
|
Labeling
|
B
|
|
|
|
Merck
|
12/10/2001
|
FALSE'
|
Antiasthmatic
|
08/26/2002
|
DUAC Topical Gel
|
clindamycin 1%/benzoyl peroxide 5%
|
Acne
|
Added combination topical treatment for mild to moderate acne
|
Labeling
|
|
|
|
R
|
Stiefel Laboratories
|
|
FALSE'
|
Antiacne, topical
|
08/30/2002
|
Nolvadex
|
tamoxifen
|
McCune-Albright Syndrome
|
A study in 28 female patients aged 2-10 years with McCune-Albright Syndrome and precocious puberty did not demonstrate safety and effectiveness. Long term effects have not been established Mean uterine volume increased after 6 months of therapy and doubled at end of 1-year study
|
Labeling
|
B
|
|
|
|
AstraZeneca
|
05/16/2002
|
FALSE'
|
Hormone
|
10/08/2002
|
Epivir
|
lamivudine
|
HIV
|
Lamivudine clearance substantially reduced in 1-week-old neonates relative to pediatric patients >3 months of age
|
Labeling
|
B
|
|
|
|
GlaxoSmithKline
|
09/22/2000
|
FALSE'
|
Antiviral
|
10/18/2002
|
Lipitor
|
atorvastatin
|
Heterozygous Familial Hypercholesterolemia
|
New indication in adolescent boys and girls (post-menarche) 10-17 years of age
|
Labeling
|
B
|
|
|
|
Pfizer
|
02/22/2002
|
FALSE'
|
Antilipemic
|
10/18/2002
|
Zocor
|
simvastatin
|
Heterozygous Familial Hypercholesterolemia
|
New indication in adolescent boys and girls (at least one year post-menarche) 10-17 years of age
|
Labeling
|
B
|
|
|
|
Merck
|
02/22/2002
|
FALSE'
|
Antilipemic
|
10/21/2002
|
Zyrtec
|
cetirizine
|
Perennial Allergic Rhinitis & Chronic Urticaria
|
Extended the age range from 2 years to 6 months Information on dose, PK parameters and AE profile
|
Labeling
|
B
|
|
|
|
Pfizer
|
03/13/2002
|
FALSE'
|
Antihistamine
|
10/29/2002
|
Pravachol
|
pravastatin
|
Heterozygous Familial Hypercholesterolemia
|
New indication in boys and girls 8-18 years of age
|
Labeling
|
B
|
|
|
|
Bristol-Myers Squibb
|
07/10/2002
|
FALSE'
|
Antilipemic
|
11/05/2002
|
Navelbine
|
vinorelbine
|
Malignant tumors
|
New data from a single-arm study in 46 patients with recurrent solid malignant tumors, including rhabdomyosarcoma /undifferentiated sarcoma, neuroblastoma, and CNS tumors, at doses similar to those used in adults showed no meaningful clinical activity
|
Labeling
|
B
|
|
|
|
GlaxoSmithKline
|
08/15/2002
|
FALSE'
|
Antineoplastic
|
11/26/2002
|
Strattera
|
atomoxetine
|
Attention-Deficit Hyperactivity Disorder
|
Safety and effectiveness established down to 6 years of age It is unknown whether final adult height or weight is affected by treatment. Patients on long-term treatment should be monitored The effectiveness of atomoxetine beyond 9 weeks and safety beyond 1 year in pediatric patients, has not been systematically evaluated in controlled trials
|
Labeling
|
B
|
|
|
|
Lilly
|
12/18/2001
|
FALSE'
|
Non-stimulant ADHD treatment
|
12/04/2002
|
Centany Ointment 2%
|
mupirocin
|
Treatment of impetigo in children 2 months of age and older
|
New dosage form: ointment that differed from already approved ointment with pediatric clinical trials to demonstrate equivalence
|
Labeling
|
|
P
|
|
|
Clay-Park Labs
|
|
FALSE'
|
Antibiotic, topical
|
12/19/2002
|
Zyvox
|
linezolid
|
Nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant infections caused by susceptible strains
|
Extended age range down to birth for nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections and vancomycin-resistant infections. Safety and efficacy extrapolated from studies in adults and supported by PK and comparator-controlled studies in patients from birth to 11 years Extended age range down to 5 years of age for uncomplicated skin and skin structure infections based upon a comparator-controlled study in 5 to 17 year olds Clearance of linezolid varies as a function of age; As age of pediatric patients increases, clearance gradually decreases, and by adolescence mean clearance values approach those observed in adults Pediatric patients exhibit wider variability in clearance and systemic exposure (AUC) compared with adults New every 8 hours dosing regimen for pediatric patients birth to 11 years of age and every 12 hours dosing regimen for pediatric patients 12 years and older Information on PK parameters, AE profile, laboratory changes, dosing, and clinical studies
|
Labeling
|
B
|
|
|
|
Pfizer
|
02/11/2005
|
FALSE'
|
Antibiotic
|
12/26/2002
|
Relpax
|
eletriptan
|
Migraine
|
Summary is pending
|
Labeling
|
|
P
|
|
|
Pfizer
|
|
FALSE'
|
Antimigraine
|
12/30/2002
|
Zovirax Cream
|
acyclovir
|
Treatment of herpes labialis (cold sores) in children 12 years and older
|
Adolescents 12-17 years of age included in clinical safety studies. dosing regimen established waived in children < 12 years of age because rarely seen in that population New dosage form
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Antiviral
|
12/31/2002
|
Singulair Oral Granules, Tablets, and Chewable Tablets
|
montelukast
|
Seasonal allergic rhinitis in children 2 years of age and older
|
Effectiveness extrapolated from studies in patients 15 years of age and older and supported with one pediatric safety trial in patients 2-14 years of age New indication
|
Labeling
|
|
P
|
|
|
Merck
|
|
FALSE'
|
Antiasthmatic; antiallergy
|
01/03/2003
|
Prozac
|
fluoxetine
|
Major Depressive Disorder (MDD) & Obsessive Compulsive Disorder (OCD)
|
Effectiveness established in patients 7-17 years of age for OCD Effectiveness established in patients 8-17 years of age for MDD FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Prozac or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Prozac is approved for use in pediatric patients with MDD and obsessive compulsive disorder (OCD). (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials Decreased weight gain has been observed in association with the use of fluoxetine, as with other SSRIs. In one 19-week clinical trial pediatric subjects treated with fluoxetine gained an average of 1.1cm less in height (p=0.004) and 1.1 kg less in weight (p=0.008) than those treated with placebo. Therefore, height and weight should be monitored periodically in pediatric patients treated with fluoxetine Mania/hypomania led to discontinuation of 1.8% of fluoxetine treated patients vs. 0% of placebo controlled patients in the three placebo-controlled trials combined. Regular monitoring for the occurrence of mania/hypomania is recommended Higher average steady state fluoxetine and norfluoxetine concentrations were observed in children than in adolescents. These differences were almost entirely explained by differences in weight Separate dosing recommendations in lower weight children
|
Labeling
|
B
|
|
|
|
Lilly
|
11/15/2000
|
FALSE'
|
Antidepressant
|
01/13/2003
|
Busulfex
|
busulfan
|
Part of a conditioning regimen administered prior to hematopoietic progenitor cell transplantation for a variety of malignant hematologic or non-malignant diseases
|
The population pharmacokinetic estimates of busulfan for clearance and volume of distribution were determined in an open-label, uncontrolled PK study in 24 pediatric patients 5 months to 16 years who received busulfan as part of a conditioning regimen administered prior to hematopoietic progenitor cell transplantation for a variety of malignant hematologic or non-malignant diseases Suggested dosing regimen
|
Labeling
|
B
|
|
|
|
Orphan Medical
|
03/12/2002
|
FALSE'
|
Antineoplastic
|
01/17/2003
|
Lamictal
|
lamotrigine
|
Adjunctive therapy for partial seizures
|
Extended indication from adults to pediatric patients e 2 years Patients aged 2 - 18 years had clearance influenced predominantly by total body weight and concurrent antiepileptic drug (AED) therapy. The oral clearance was higher, on a body weight basis, in pediatric patients than in adults Because of increased clearance in pediatrics, maintenance doses in patients weighing < 30 kg may need an increase of as much as 50% based upon clinical response Evidence shows that the inclusion of VPA in a multi-drug regimen increases the risk of serious, potentially life-threatening rash in pediatric patients Approximately 11.5% of the 1,081 pediatric patients who received the drug as adjunctive therapy in clinical trials discontinued treatment because of an AE
|
Labeling
|
B
|
|
|
|
GlaxoSmithKline
|
02/14/2007
|
FALSE'
|
Anticonvulsant
|
02/26/2003
|
Pulmicort
|
budesonide
|
Maintenance and Prophylaxis of Asthma
|
Safety information in pediatric patients 6 to 12 months of age A dose dependent effect on growth was observed in the 12-week trial which supports the finding that the use of Pulmicort Respules in infants 6 to 12 months of age may result in systemic effects and is consistent with the findings of growth suppression in other studies with inhaled corticosteroids Pneumonia was observed more frequently in patients treated with Pulmicort Respules than in patients treated with placebo
|
Labeling
|
B
|
|
|
|
AstraZeneca
|
11/12/2002
|
FALSE'
|
Antiasthmatic
|
03/11/2003
|
Temodar
|
temozolomide
|
Recurrent CNS tumors
|
Temozolomide effectiveness in children has not been demonstrated New data from 2 open-label Phase 2 studies in pediatric patients 3-18 years of age. In one study there were 29 patients with recurrent brain stem glioma and 34 patients with recurrent high grade astrocyoma. In a second study there were 122 patients enrolled with various types of tumors; 113 CNS tumors and 9 non-CNS tumors. The temozolomide toxicity profile in children is similar to adults
|
Labeling
|
B
|
|
|
|
Schering
|
11/20/2002
|
FALSE'
|
Antineoplastic
|
04/15/2003
|
Vigamox
|
moxifloxacin
|
Bacterial Conjunctivitis
|
Safety and effectiveness established down to 1 year of age
|
Labeling
|
B
|
|
|
|
Alcon
|
01/10/2003
|
FALSE'
|
Antibiotic, topical
|
04/15/2003
|
Ditropan & Ditropan XL
|
oxybutynin
|
Detrusor Overactivity Associated with a Neurological Condition
|
Ditropan Additional information on dose and PK parameters Precautions section of label updated Ditropan XL Safety and effectiveness established down to 6 years of age
|
Labeling
|
B
|
|
|
|
Johnson & Johnson
|
02/08/2002
|
FALSE'
|
Urology
|
04/15/2003
|
Methylin Chewable Tablets
|
methylphenidate
|
Treatment of Attention-Deficit Hyperactivity Disorder in children 6 years of age and older treatment of narcolepsy in children 6 years of age and older
|
Bioequivalence studies in adults New dosage form
|
Labeling
|
|
P
|
|
|
Mallinckrodt
|
|
FALSE'
|
CNS Stimulant
|
05/01/2003
|
Flonase Nasal Spray & Cultivate Ointment
|
fluticasone
|
Flonase - nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis Cutivate Ointment - corticosteroid-responsive dermatoses
|
Flonase New data from 1-year placebo-controlled clinical growth study in pediatric patients 3-9 years of age; no statistically significant effect on growth was noted compared to placebo. No evidence of clinically relevant changes in HPA axis function or bone mineral density was observed as assessed by 12-hour urinary cortisol excretion and dual-energy x-ray absorptiometry, respectively. Cutivate Indicated for use only in adult patients In a study of 35 pediatric patients treated for atopic dermatitis, subnormal adrenal function was observed with cosyntropin stimulation testing
|
Labeling
|
B
|
|
|
|
GlaxoSmithKline
|
02/25/2003
|
FALSE'
|
Anti-inflammatory, topical
|
05/12/2003
|
Allegra
|
fexofenadine
|
Allergic rhinitis
|
Three clinical safety studies in 845 children with allergic rhinitis are described in the label
|
Labeling
|
B
|
|
|
|
Aventis
|
01/27/2003
|
FALSE'
|
Antihistamine
|
05/20/2003
|
Duragesic
|
fentanyl
|
Management of chronic pain
|
Safety evaluated in three open-label trials in 291 patients 2 years through 18 years of age with chronic pain New Warning: Duragesic should be administered to children only if they are opioid-tolerant and age 2 years or older New information on pharmacokinetics, dosage and administration and patient information Precaution to guard against accidental ingestions by children Adverse Events: no apparent pediatric-specific risk associated with Duragesic use in children as young as 2 years old when used as directed. Most common adverse events were fever (35%), vomiting (33%), and nausea (24%)
|
Labeling
|
B
|
|
|
|
Alza
|
01/29/2003
|
FALSE'
|
Anesthetic agent
|
05/23/2003
|
Duocaine Injection
|
bupivacaine; lidocaine
|
Local regional anesthesia for ophthalmologic surgery by peripheral nerve block techniques in children 12 years of age and older
|
Safety and effectiveness extrapolated from existing clinical database Safety and effectiveness not established in patients < 12 years of age Partial waiver 0-12 years of age because general anesthesia is preferred in that population New active ingredient
|
Labeling
|
|
P
|
|
|
Amphastar
|
|
FALSE'
|
Anesthetic, topical
|
05/27/2003
|
Monopril
|
fosinopril
|
Hypertension
|
New data from a double-blind study in 252 patients 6-16 years of age New recommended dose in children weighing more than 50kg New Information on PK parameters An appropriate dosage strength is not available for children weighing less than 50kg
|
Labeling
|
B
|
|
|
|
Bristol-Myers Squibb
|
01/27/2003
|
FALSE'
|
Antihypertensive
|
05/29/2003
|
Prinivil
|
lisinopril
|
Hypertension
|
Labeling for 6-16 years of age Not recommended for pediatric patients with glomerular filtration rate < 30ml/min/1.73m2 Information on dose, efficacy and pharmacokinetics No relevant differences were identified between adverse experience profile for pediatric patients and that previously reported for adult patients Information on preparation of a suspension
|
Labeling
|
B
|
|
|
|
Merck
|
11/19/2001
|
FALSE'
|
Antihypertensive
|
07/01/2003
|
Zestril
|
lisinopril
|
Hypertension
|
Labeling for 6-16 years of age Not recommended for pediatric patients less than 6 years or with glomerular filtration rate < 30mL/min/1.73m2 Information on dose, efficacy and pharmacokinetics No relevant differences were identified between adverse experience profile for pediatric patients and that previously reported for adult patients Information on preparation of a suspension
|
Labeling
|
B
|
|
|
|
AstraZeneca
|
11/19/2001
|
FALSE'
|
Antihypertensive
|
07/18/2003
|
Ciprodex Sterile Otic Suspension
|
ciprofloxacin; dexamethasone
|
Treatment of acute otitis media in patients with tympanostomy tubes (inner ear infection) in children 6 months of age and older treatment of acute otitis externa (outer ear infection) in children 6 months of age and older
|
Over 700 pediatric patients in safety and effectiveness studies to support both indications Pediatric dosing information added New dosage form
|
Labeling
|
|
P
|
|
|
Alcon
|
|
FALSE'
|
Antibiotic, topical
|
08/01/2003
|
Fludara
|
fludarabine
|
Refractory acute leukemia and solid tumors
|
Fludarabine was evaluated in 62 pediatric patients and the data were insufficient to establish efficacy in any childhood malignancy
|
Labeling
|
B
|
|
|
|
Berlex
|
04/03/2003
|
FALSE'
|
Antineoplastic
|
09/30/2003
|
Floxin Otic Solution
|
ofloxacin
|
Treatment of otitis externa (outer ear infection) in children 6 months of age and older
|
Dosing change from 2 times daily to 1 time daily for 7 days based on effectiveness and safety studies that included pediatric patients New dosing regimen
|
Labeling
|
|
P
|
|
|
Daiichi
|
|
FALSE'
|
Antibiotic
|
10/10/2003
|
Denavir Cream
|
penciclovir
|
Treatment of recurrent herpes labialis (cold sores) in children 12 years of age and older
|
Extended indication down from 18 years of age to 12 years of age Effectiveness extrapolated from adult studies Safety study in patients 12-17 years of age Pediatric submission
|
Labeling
|
|
P
|
|
|
Novartis
|
|
FALSE'
|
Antiviral, topical
|
10/16/2003
|
Elestat Ophthalmic Solution
|
epinastine
|
Prevention of itching associated with allergic conjunctivitis in children 3 years of age and older
|
Based on effectiveness and safety studies that included children down to 10 years of age Partial waiver for children < 3 years of age because the condition does not exist in the age group New drug
|
Labeling
|
|
P
|
|
|
Allergan
|
|
FALSE'
|
Antihistamine, topical
|
12/02/2003
|
Malarone
|
atovaquone/ proguanil
|
Prophylaxis and treatment of malaria
|
Safety and effectiveness established down to e 11kg Information on dose, efficacy, PK parameters and AE profile Elimination half-life is shorter in pediatric patients (1 to 2 days) than in adults (2 to 3 days) Attributable AEs occurring in ³ 5% of the pediatric patients were vomiting (10%) and pruritus (6%)
|
Labeling
|
B
|
|
|
|
GlaxoSmithKline
|
08/06/2003
|
FALSE'
|
Antimalarial
|
12/10/2003
|
Ertaczo Cream
|
sertaconazole
|
Treatment of interdigital tinea pedis (athlete's foot) in children 12 years of age and older
|
Safety and effectiveness established in clinical trials involving adolescent patients Studies in patients less than 12 years of age waived because there are too few children with the disease to study New drug
|
Labeling
|
|
P
|
|
|
Mylan
|
|
FALSE'
|
Antifungal, topical
|
12/12/2003
|
Xenical
|
orlistat
|
Obesity management
|
Use in 12-16 year olds is supported by studies in adults with additional data from a 54 week safety and efficacy study in obese adolescent patients. Since orlistat can reduce absorption of fat soluble vitamins, all patients should take a daily multivitamin supplement containing fat soluble vitamins. Adverse event profile in adolescent patients was similar to that seen in adults
|
Labeling
|
B
|
|
|
|
Roche
|
09/12/2003
|
FALSE'
|
Obesity management
|
01/08/2004
|
Norvasc
|
amlodipine
|
Hypertension
|
Information on dose, PK in pediatric patients 6-17 years of age Adverse event profile in pediatric patients was similar to that seen in adults
|
|
B
|
|
|
|
Pfizer
|
11/27/2001
|
FALSE'
|
Antihypertensive
|
01/15/2004
|
Zithromax Tablets
|
azithromycin
|
Treatment of acute bacterial sinusitis (sinus infection) in patients 6 months of age and older
|
Effectiveness extrapolated from adult sinusitis studies and from pediatric acute otitis media studies Clinical studies conducted in pediatric patients 3 years to 16 years of age to determine PK and safety for oral suspension Safety and effectiveness in patients under 6 months of age have not been established Side effects seen in pediatric patients were comparable to those seen in adults, with different incidence rates for the dosage regimens recommended in pediatric patients Dosing regimen established Partial waiver < 6 months of age because too few patients to study New indication
|
Labeling
|
|
P
|
|
|
Pfizer
|
|
FALSE'
|
Antibiotic
|
02/24/2004
|
Children's Advil Allergy Sinus Suspension
|
chlorpheniramine; ibuprofen; pseudoephedrine
|
Symptoms of allergic rhinitis (runny nose) and the common cold in children 6 years of age and older
|
Effectiveness extrapolated from adult studies Bioequivalence studies in healthy adults PK and safety studies in children 6 to 12 years of age New dosage form
|
Labeling
|
|
P
|
|
|
Wyeth Consumer Healthcare
|
|
FALSE'
|
Antihistamine
|
02/27/2004
|
Myfortic Delayed-Release Tablets
|
mycophenolic acid
|
Prevention of organ rejection in patients receiving allogeneic renal transplants in children 5-16 years of age with stable renal transplants
|
Approval based on extrapolation of safety and effectiveness in adult patients One PK study with information down to 5 years of age Waived studies in birth to 10 years because there are too few children to study. New active ingredient
|
Labeling
|
|
P
|
|
|
Novartis
|
|
FALSE'
|
Immunosuppressant
|
03/02/2004
|
Lotensin
|
benazepril
|
Hypertension
|
Information on dose, PK in pediatric patients 6-16 years of age Not recommended for pediatric patients less than 6 years or with glomerular filtration rate < 30mL/min/1.73 m2 due to insufficient data Infants below the age of 1 year should not be given ACE inhibitors due to concerns over possible effects on kidney development The clearance rate was substantially higher in hypertensive children and adolescents than that of healthy adults The terminal half life (t1/2) in pediatric patients was one third of that observed in adults Adverse event profile in pediatric patients was similar to that seen in adults Information on preparation of a suspension
|
Labeling
|
B
|
|
|
|
Novartis
|
07/02/2003
|
FALSE'
|
Antihypertensive
|
03/05/2004
|
Arava
|
leflunomide
|
Polyarticular Juvenile Rheumatoid Arthritis
|
Safety and efficacy in pediatric patients with polyarticular JRA have not been fully evaluated 94 patients with polyarticular JRA were studied in a double-blind active controlled trial (1:1 randomization); approximately 68% of pediatric patients receiving Arava versus 89% receiving active comparator demonstrated improvement on the primary endpoint by week 16 Pediatric patients with a body weight d 40 kg have a reduced clearance relative to adult rheumatoid arthritis patients Information on PK of M1, the active metabolite responsible for in vivo activity in children 3-17 years old Most common adverse events in 74 polyarticular JRA patients 3-17 years old included abdominal pain, diarrhea, nausea, vomiting, oral ulcers, upper respiratory tract infections, alopecia, rash, headache, and dizziness 14 of the 74 patients experienced ALT and/or AST elevations; 5/14 were between 3 and 8 fold the upper limit of normal
|
Labeling
|
|
|
B, P
|
|
Aventis
|
11/10/2003
|
FALSE'
|
Anti-inflammatory
|
03/08/2004
|
Ultiva
|
remifentanil
|
Maintenance of anesthesia
|
Safety and efficacy for the maintenance of anesthesia established from birth to 1 year of age Recommended dosing guidelines for maintenance of anesthesia for patients from birth to 2 months The clearance rate observed in neonates was highly variable approximately 2 times higher than young healthy adults Individual doses for each patient should be carefully titrated
|
Labeling
|
|
|
B, P
|
|
Abbott
|
03/15/2000
|
FALSE'
|
Anesthetic agent
|
03/11/2004
|
Cozaar
|
losartan
|
Hypertension
|
Antihypertensive effects established in hypertensive patients 6-16 years of age Not recommended for pediatric patients less than 6 years or with glomerular filtration rate < 30mL/ min/1.73 m2 due to no data Information on PK and dose in pediatric patients 6-16 years of age. No relevant differences between the AE profile for pediatric patients compared to reported AEs for adults Information on preparation of a suspension
|
Labeling
|
B
|
|
|
|
Merck
|
03/20/2002
|
FALSE'
|
Antihypertensive
|
03/15/2004
|
Glucovance
|
glyburide/ metformin
|
Type 2 Diabetes Mellitus
|
As studied in active-controlled, double blind trial in pediatric patients (9 16 years of age), Glucovance was not statistically superior to either metformin or glyburide in reducing HbA1C from baseline No unexpected safety findings
|
Labeling
|
B
|
|
|
|
Bristol-Myers Squibb
|
10/08/2003
|
FALSE'
|
Antidiabetic
|
03/19/2004
|
Viracept
|
nelfinavir
|
HIV-1
|
Safety and effectiveness established in patients 2 13 years of age New twice daily dosing regimen and modified three times daily dosing for pediatric patients > 2 years A reliably effective dose not established in patients <2 years of age PK information in pediatric patients from birth to 13 years of age Highly variable drug exposure is a significant problem in pediatric patients Adverse event profile was similar to that for adults
|
Labeling
|
|
|
B, P
|
|
Pfizer
|
09/04/2003
|
FALSE'
|
Antiviral
|
03/25/2004
|
Cipro
|
ciprofloxacin
|
Complicated UTI and pyelonephritis
|
Indicated for the treatment of complicated urinary tract infections (cUTIs) and pyelonephritis in pediatric patients 1 17 years of age Not drug of first choice due to increased adverse events compared to controls including events related to joints and/or surrounding tissues Information on PK and dose in pediatric patients 1 17 years of age The most frequent adverse events observed within 6 weeks of treatment initiation during the cUTI clinical trial were gastrointestinal 15% compared to 9% and musculoskeletal 9.3% compared to 6% in ciprofloxacin-treated compared to control-treated patients, respectively
|
Labeling
|
B
|
|
|
|
Bayer
|
12/18/2003
|
FALSE'
|
Antibiotic
|
03/31/2004
|
Zemplar
|
paricalcitol
|
Secondary hyperparathyroidism associated with end stage renal disease
|
Safety and effectiveness were examined in a 12 week randomized, double-blind, placebo-controlled study of 29 pediatric patients aged 5-19 years old with end stage renal disease on hemodialysis; information Primary efficacy analysis revealed 9 of 15 patients in Zemplar group had 2 consecutive 30 % decreases from baseline intact PTH compared with 3 of 14 patients in placebo group No patients in either group developed hypercalcemia (defined as at least one calcium value >11.2 mg/dL) during study
|
Labeling
|
B
|
|
|
|
Abbott
|
12/08/2003
|
FALSE'
|
Vitamin D analog
|
04/01/2004
|
Corlopam
|
fenoldopam
|
Indicated for the in-hospital, short-term reduction in blood pressure
|
Indicated for the in-hospital, short-term (up to 4 hours) reduction in blood pressure in pediatric patients <1 month (at least 2 kg) to 12 years of age Information on PK, dose and AE profile Clinical studies did not include patients 12 16 years of age
|
Labeling
|
B
|
|
|
|
Hospira
|
|
FALSE'
|
Antihypertensive
|
04/14/2004
|
Trusopt
|
dorzolamide
|
Reduction in intraocular pressure
|
Safety and IOP-lowering effects have been demonstrated in pediatric patients Adverse event profile was comparable to that seen in adults
|
Labeling
|
B
|
|
|
|
Merck
|
01/05/2004
|
FALSE'
|
Ophthalmologic hypotensive
|
04/14/2004
|
Detrol LA
|
tolterodine
|
Urinary frequency and urge incontinence due to neurogenic conditions
|
Efficacy in pediatric population has not been demonstrated The dose-plasma concentration relationship is linear in patients from 11 to 15 years Parent/ metabolite ratios differed according to CYP2D6 metabolizer status 710 pediatric patients ages 5 -10 years with urinary frequency and urge incontinence were studied in 2 randomized placebo controlled trials. Urinary tract infections were higher in patients treated with Detrol LA (6.6%) compared to placebo (4.5%) Aggressive, abnormal and hyperactive behavior and attention disorders occurred in 2.9% of children treated with Detrol LA compared to 0.9% treated with placebo
|
Labeling
|
B
|
|
|
|
Pfizer
|
01/05/2004
|
FALSE'
|
Urology
|
04/21/2004
|
Advair Diskus
|
fluticasone/ salmeterol
|
Asthma
|
Extended indication from 12 years down to 4 years of age
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Antiasthmatic
|
04/29/2004
|
Mucinex DM Extended-release Tablet
|
guaifenesin; dextromethorphan
|
Expectorant and cough suppressant in children 12 years of age and older
|
505(b)(2) approved with no pediatric information Age range based on monograph Do not use in children under 12 years of age studies waived in children < 12 years of age due to safety concerns New dosage form
|
Labeling
|
|
P
|
|
|
Adams Respiratory Therapeutics
|
|
FALSE'
|
Cough suppressant
|
05/05/2004
|
Effexor and Effexor XR
|
venlafaxine
|
Major Depressive Disorder
|
Effectiveness in pediatric patients has not been established FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Effexor or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Effexor is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials. 18% of Effexor XR treated patients (6-17 years) versus 3.6 % of placebo treated patients experienced a weight loss of at least 3.5 % in both MDD and the GAD studies In an open-label study increases in weight were less than expected based on data from age and sex matched peers. The difference between observed weight gain was larger for children less than 12 years than for adolescents older than 12 years During an 8 week placebo controlled GAD trial, Effexor XR treated patients ages 6-17 years grew an average of 0.3 cm, while placebo treated patients grew an average of 1 cm. In a 6 month open-label study, height increases that were less than expected based on data from age and sex matched pairs. The difference between observed and expected growth rates were larger for children less than 12 years than for adolescents older than 12 years Decreased appetite observed in 10% of patients ages 6-17 years old receiving Effexor XR Occurrence of blood pressure and cholesterol increases considered clinically relevant in pediatric patients similar to that observed in adults
|
Labeling
|
|
|
B, P
|
|
Wyeth
|
12/02/2002
|
FALSE'
|
Antidepressant
|
05/06/2004
|
Lidosite Topical System Kit
|
epinephrine; lidocaine
|
Topical local analgesia for superficial dermatological procedures in children 5 years of age and older
|
505(b)(2) with clinical studies Safety and effectiveness established in studies of pediatric patients 5-18 years of age PK study in pediatric patients 6-15 years of age dosing regimen established in clinical trials Studies in patients 0-5 years of age deferred New dosage form; new route of administration
|
Labeling
|
|
P
|
|
|
Vyteris
|
|
FALSE'
|
Anesthetic, topical
|
05/25/2004
|
Axid
|
nizatidine
|
Esophagitis, and heartburn due to GERD
|
Indicated in pediatric patients 12 years and older Information on dose, PK parameters, and AE profile
|
Labeling
|
B
|
|
|
|
Reliant Pharms
|
|
FALSE'
|
Antiulcerative
|
06/02/2004
|
Humalog Injection
|
insulin lispro
|
Treatment of patients with diabetes mellitus for the control of hyperglycemia (high blood sugar) in children 3-11 years of age
|
Safety and effectiveness established from studies in patients 3-11 years of age Dosing information added for external insulin pumps New route of administration
|
Labeling
|
|
P
|
|
|
Lilly
|
|
FALSE'
|
Antidiabetic
|
06/17/2004
|
Prevacid
|
lansoprazole
|
Short-term treatment of symptomatic GERD and erosive Esophagitis
|
Expanded age range to include patients 12 -17 years of age; previously labeled only in pediatric patients 1-11 years of age Safety and effectiveness in pediatric patients <1 year of age have not been established Information on dose, PK parameters, and AE profile
|
Labeling
|
B
|
|
|
|
Tap
|
07/15/2008
|
FALSE'
|
Antiulcerative
|
06/21/2004
|
Codeprex Extended-Release Suspension
|
chlorpheniramine; codeine
|
Temporary relief of cough associated with the common cold or inhaled irritants; temporary relief of symptoms of hay fever, other upper respiratory allergies, or allergic rhinitis in children 6 years of age and older OTC
|
Approval and age range based on monograph for antitussives and antihistamine No clinical studies submitted Studies in children < 6 years of age deferred New dosage form; new dosing regimen
|
Labeling
|
|
P
|
|
|
Celltech Pharmaceuticals
|
|
FALSE'
|
Antihistamine
|
06/24/2004
|
TamiFlu
|
oseltamivir
|
Treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older
|
Not recommended in pediatric patients less than 1 year of age because of uncertainties regarding the rate of development of the human blood-brain barrier and the unknown clinical significance of animal toxicology data for human infants
|
Labeling
|
B
|
|
|
|
Roche
|
03/22/2004
|
FALSE'
|
Antiviral
|
06/24/2004
|
Camptosar
|
irinotecan
|
Refractory solid tumors
|
Effectiveness in pediatric patients has not been established Adverse event profile from a Phase 2 trial with 170 children with refractory solid tumors comparable to that seen in adults; Grade 3-4 neutropenia experienced by 54 (31.8%) patients, neutropenia complicated by fever in 15 (8.8%) patients, Grade 3-4 diarrhea observed in 35 (20.6%) patients. Accrual for phase 2 study with 21 children with previously untreated rhabdomyosarcoma halted due to high rate (23.6%) of progressive disease and early deaths (14%) Adverse event profile seen in the 21 children different than that observed in adults; most significant Grade 3 or 4 adverse events were dehydration experienced by 6 patients (28.6%) associated with severe hypokalemia in 5 patients (23.8%) and hyponatremia in 3 patients (14.3%); in addition Grade 3-4 infection was reported in 5 patients (23.8%)(across all courses of therapy and irrespective of causal relationship) PK parameters comparable to adults Minimal accumulation of irinotecan and SN-38 (active metabolite) observed in children on daily dosing
|
Labeling
|
B
|
|
|
|
Pfizer
|
03/10/2004
|
FALSE'
|
Antineoplastic
|
07/30/2004
|
Claritin-D 12 Hour Extended-Release Tablets Claritin-D 24 Hour Extended-Release Tablets
|
loratadine; pseudoephedrine
|
Temporary relief of nasal congestion due to the common cold in children 12 years of age and older OTC
|
Approval based on monograph and previous studies for other indication No new studies submitted Studies in children birth - 12 years of age waived New indication
|
Labeling
|
|
P
|
|
|
Schering-Plough
|
|
TRUE'
|
Antihistamine
|
08/13/2004
|
Ferrlecit
|
sodium ferric gluconate complex
|
Iron deficiency anemia in chronic hemodialysis patients receiving supplemental erythropoietin therapy
|
Safety and effectiveness established in pediatric patients 6 -15 years old Patients <6 years of age not studied Information on dose, PK parameters and AE profile
|
Labeling
|
|
|
B, P
|
|
Watson
|
03/24/2004
|
FALSE'
|
Vitamin
|
08/19/2004
|
Vioxx
|
rofecoxib
|
Pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis
|
Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib) due to safety concerns on September 30, 2004.
|
Labeling
|
B
|
|
|
|
Merck
|
02/18/2004
|
FALSE'
|
Anti-inflammatory
|
09/01/2004
|
Clarinex
|
desloratadine
|
Seasonal and perennial allergic rhinitis, and the symptomatic relief of pruritus, and hives
|
Indicated for seasonal allergic rhinitis down to 2 years of age. Extended age range down to 6 months for perennial allergic rhinitis and chronic idiopathic urticaria Safety and effectiveness of tablets or syrup has not been established in pediatric patients less than 6 months of age Information on dose, PK parameters, and AE profile in pediatric patients 6 months - 11 years of age
|
Labeling
|
B
|
|
|
|
Schering
|
02/12/2003
|
FALSE'
|
Antihistamine
|
09/29/2004
|
Amlexanox Mucoadhesive Patch
|
amlexanox
|
Treatment of apthous ulcers in children 12 years of age and older
|
Approval based on monograph and previous studies for other indication No new studies submitted Studies in children birth 12 years of age waived New indication
|
Labeling
|
|
P
|
|
|
Access Pharmaceuticals
|
|
TRUE'
|
Anti-inflammatory, topical
|
10/13/2004
|
Imitrex Nasal Spray
|
sumatriptan
|
Migraine
|
Five clinical trials evaluating oral sumatriptan in pediatric patients ages 12 -17 years did not establish the safety and effectiveness when compared to placebo Postmarketing experience documents that serious AEs rarely reported in adults, including stroke, visual loss, and death have occurred in the pediatric population after use of subcutaneous, oral, and/ or nasal sumatriptan. Since clinical data to determine the frequency of serious adverse events in pediatric patients who might receive injectable, oral, and/ or intranasal sumatriptan are not presently available, the use of sumatriptan in patients aged younger than 18 years is not recommended
|
Labeling
|
B
|
|
|
|
Glaxo
|
02/18/2004
|
FALSE'
|
Antimigraine
|
10/21/2004
|
Concerta
|
methylphenidate
|
ADHD
|
Expanded labeling for 13-17 year olds including information on dose, PK parameters, and AE profile Increase in age resulted in increased apparent oral clearance For patients new to methylphenidate: higher maximum recommended dosage for adolescents compared to children 6-12 years of age Data are inadequate to determine whether chronic use of stimulants in children may cause suppression of growth. Therefore, growth should be monitored during treatment Safety and efficacy in children <6 years have not been established
|
Labeling
|
B
|
|
|
|
Alza
|
12/04/2003
|
FALSE'
|
CNS Stimulant
|
11/16/2004
|
Zomig
|
zolmitriptan
|
Migraine
|
Clinical trial evaluating zolmitriptan in pediatric patients ages 12 -17 years did not establish the safety and effectiveness when compared to placebo AEs observed in clinical trials were similar to those observed in clinical trials in adults.
|
Labeling
|
B
|
|
|
|
AstraZeneca
|
12/18/2003
|
FALSE'
|
Antimigraine
|
12/10/2004
|
Agrylin
|
anagrelide
|
Myeloproliferative disorders
|
An open-label study evaluated PK/PD but not efficacy. Information on PK/PD profile, dosing, AEs, and safety in patients > 6 years to 17 years No overall difference in dosing and safety were observed between pediatric and adult patients Established recommended starting dose based on limited data. Dosage should be adjusted to the lowest effective dosage
|
Labeling
|
B
|
|
|
|
Shire
|
05/25/2004
|
FALSE'
|
Hematology/Coagulation
|
12/16/2004
|
VisionBlue Ophthalmic Solution
|
trypan blue
|
Aid in ophthalmic surgery by staining anterior capsule
|
Approved for use in all populations based on information from clinical trials in the literature New drug
|
Labeling
|
|
P
|
|
|
DORC International
|
|
FALSE'
|
Ophthalmologic stain
|
12/17/2004
|
Augmentin ES-600 Powder for Oral Suspension
|
amoxicillin; clavulanate
|
Treatment of acute bacterial sinusitis (ABS) (sinus infection) in children 3 months of age and older
|
No new pediatric studies Effectiveness extrapolated from adult studies for Augmentin XR for ABS and from studies in pediatric patients with otitis media and by similar pharmacokinetics in pediatric patients New indication
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
TRUE'
|
Antibiotic
|
12/22/2004
|
Pataday Ophthalmic Solution
|
olopatadine
|
Treatment of ocular itching associated with allergic conjunctivitis (itchy eyes) in children 3 years of age and older
|
Based on clinical trials that included patients down to 3 years of age. New indication
|
Labeling
|
|
P
|
|
|
Alcon
|
|
FALSE'
|
Antihistamine, topical
|
12/28/2004
|
Clolar
|
clofarabine
|
Relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens
|
Labeling for patients 1 to 21 years old. This use is based on the induction of complete responses Randomized trials demonstrating increased survival or other clinical benefit have not been conducted Information on dose, PK parameters, and AE profihe
|
Labeling
|
B
|
|
|
|
Genzyme
|
07/14/2004
|
FALSE'
|
Antineoplastic
|
01/12/2005
|
Serzone
|
nefazodone
|
Major Depressive Disorder
|
Safety and effectiveness in the pediatric population have not been established FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Serzone or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Serzone is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials Two placebo-controlled trials in 286 pediatric patients with MDD have been conducted with Serzone, and the data were not sufficient to support a claim for use in pediatric patients
|
Labeling
|
B
|
|
|
|
Bristol-Myers Squibb
|
06/27/2002
|
FALSE'
|
Antidepressant
|
01/12/2005
|
Remeron
|
mirtazapine
|
Major Depressive Disorder
|
Safety and effectiveness in the pediatric population have not been established FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Remeron or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Remeron is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials Two placebo-controlled trials in 258 pediatric patients with MDD have been conducted with Remeron and the data were not sufficient to support a claim for use in pediatric patients
|
Labeling
|
B
|
|
|
|
Organon
|
|
FALSE'
|
Antidepressant
|
01/12/2005
|
Paxil
|
paroxetine
|
Major Depressive Disorder
|
Safety and effectiveness in the pediatric population have not been established FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Paxil or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Paxil is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials Three placebo-controlled trials in 752 pediatric patients with MDD have been conducted with Paxil, and the data were not sufficient to support a claim for use in pediatric patients
|
Labeling
|
B
|
|
|
|
Glaxo
|
06/27/2002
|
FALSE'
|
Antidepressant
|
02/18/2005
|
Zoloft
|
sertraline
|
Major Depressive Disorder and Obsessive Compulsive Disorder
|
Safety and effectiveness in the pediatric population other than pediatric patients with OCD have not been established FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Zoloft or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Zoloft is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See Warnings and Precautions: Pediatric Use) Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials Two placebo controlled trials in 373 pediatric patients with MDD have been conducted with Zoloft, and the data were not sufficient to support a claim for use in pediatric patients
|
Labeling
|
B
|
|
|
|
Pfizer
|
02/01/2002
|
FALSE'
|
Antidepressant
|
02/18/2005
|
Celexa
|
citalopram
|
Major Depressive Disorder
|
Safety and effectiveness in the pediatric population have not been established FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Celexa or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Celexa is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials Two placebo-controlled trials in 407 pediatric patients with MDD have been conducted with Celexa, and the data were not sufficient to support a claim for use in pediatric patients
|
Labeling
|
B
|
|
|
|
Forest
|
07/12/2002
|
FALSE'
|
Antidepressant
|
03/03/2005
|
Clarinex D 24 Hour Extended Release Tablets
|
desloratadine/pseudoephedrine
|
Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in patients 12 years of age and older
|
Two safety and effectiveness studies conducted in patients 12 years of age and older PK study Studies waived in children < 12 years of age New active ingredient; new dosing regimen
|
Labeling
|
|
P
|
|
|
Schering
|
|
FALSE'
|
Antihistamine
|
03/11/2005
|
Rapamune
|
sirolimus
|
Prophylaxis of organ rejection in patients undergoing renal transplants
|
Safety and efficacy established in children 13 years or older judged to be at low to moderate immunologic risk Safety was assessed in a controlled clinical trial in pediatric (<18 years of age) renal transplant recipients considered high immunologic risk. The use of Rapamune in combination with calcineurin inhibitors and corticosteroids was associated with an increased risk of deterioration of renal function, lipid abnormalities, and urinary tract infections Safety and efficacy have not been established in pediatric patients less than 13 years old or in pediatric renal transplant recipients considered at high immunologic risk Information on PK parameters, adverse events and safety
|
Labeling
|
B
|
|
|
|
Wyeth
|
11/17/2004
|
FALSE'
|
Immunosuppressant
|
03/11/2005
|
Xopenex HFA Inhalation Aerosol
|
levalbuterol
|
Treatment of bronchospasm in patients with reversible obstructive airway disease in children 4 years of age and older
|
Extended indication for use in children down from 6 years of age Pediatric patients have a lower exposure to the drug than adults Population PK model developed from patients down to 4 years of age Effectiveness and safety established from studies in adults, adolescents (12 years of age and older) and children ages 4-11 years of age with asthma. Deferred studies in patients < 4 years of age New active ingredient
|
Labeling
|
|
P
|
|
|
Sepracor
|
|
FALSE'
|
Antiasthmatic
|
03/25/2005
|
Zofran
|
ondansetron
|
Prevention of chemotherapy-induced and postoperative induced nausea and vomiting
|
Established dosing for surgical patients down to 1 month from 2 years of age Established dosing for cancer patients down to 6 months from 4 years of age Surgical and cancer patients < 18 years tend to have a higher ondansetron clearance compared to adults leading to a shorter half-life in most pediatric patients The clearance of ondansetron in patients 1- 4 months of age is slower and the half-life is approximately 2.5 fold longer than patients who are > 4 24 months of age Patients < 4 months of age receiving this drug should be closely monitored Additional information on dose, PK parameters, AE profile and safety
|
Labeling
|
B
|
|
|
|
GlaxoSmithKline
|
12/01/2004
|
FALSE'
|
Antiemetic
|
03/30/2005
|
Asmanex Twisthaler
|
mometasone furoate
|
Maintenance treatment of asthma as prophylactic therapy
|
Approved for use in 12 years and older
|
Labeling
|
|
P
|
|
|
Schering
|
|
FALSE'
|
Antiasthmatic
|
04/26/2005
|
Gemzar
|
gemcitabine
|
Refractory leukemia
|
Effectiveness in pediatric patients has not been demonstrated Phase 1 trial in pediatric patients with refractory leukemia demonstrated a maximum tolerated dose; however, no meaningful clinical activity observed in a Phase 2 trial of gemcitabine in 22 patients with relapsed acute lymphoblastic leukemia and 10 patients with acute myelogenous leukemia Toxicities observed were similar to those reported in adults
|
Labeling
|
B
|
|
|
|
Lilly
|
01/27/2005
|
FALSE'
|
Antineoplastic
|
05/06/2005
|
Doryx Delayed-Release Tablets
|
doxycycline
|
Treatment of infections
|
No new clinical studies submitted PK data Dosing information for new dosage form (to decrease esophagitis seen from capsules) New dosage form
|
Labeling
|
|
P
|
|
|
Warner Chilcott
|
|
TRUE'
|
Antibiotic
|
05/12/2005
|
Zyvox
|
linezolid
|
Central nervous system infections
|
PK data in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) concentrations; therapeutic concentrations were not consistently achieved or maintained in the CSF Use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended Additional information on efficacy in pediatric patients with infectious vancomycin-resistant Enterococcus faecium
|
Labeling
|
B
|
|
|
|
Pfizer
|
02/11/2005
|
FALSE'
|
Antibiotic
|
05/13/2005
|
Ortho Tri-Cyclen
|
norgestimate/ ethinyl estradiol
|
Evaluation of total hip bone mineral density in adolescent females with anorexia nervosa
|
No significant difference between Ortho Tri-Cyclen and placebo in mean change in total lumbar spine (L1-L4) and total hip bone mineral density in 123 adolescent females with anorexia nervosa in a double-blind, placebo-controlled, multicenter, one-year clinical trial
|
Labeling
|
B
|
|
|
|
Ortho McNeil
|
12/18/2003
|
FALSE'
|
Contraceptive
|
05/18/2005
|
Invanz
|
ertapenem
|
Complicated Intra-abdominal Infections; Complicated Skin and Skin Structure Infections; Community Acquired Pneumonia; Complicated Urinary Tract Infections; Acute Pelvic Infections
|
Approved for use down to 3 months of age. Efficacy extrapolated from studies in adults and supported by PK and safety studies in pediatric patients Not recommended in infants under 3 months of age as no data are available Not recommended in the treatment of meningitis in the pediatric population due to lack of sufficient CSF penetration Information on dose, PK parameters, AE profile and clinical studies
|
Labeling
|
B
|
|
|
|
Merck
|
02/11/2005
|
FALSE'
|
Antibiotic
|
05/25/2005
|
Merrem I.V.
|
meropenem
|
Treatment of complicated skin and skin structure infections in children 3 months of age and older
|
*Supported by extrapolating safety and effectiveness from an adequate and well-controlled adult study and additional data from pediatric PK studies. *Studies waived for children < 3 months of age. *New indication.
|
[INVALID]
|
|
P
|
|
|
AstraZeneca
|
|
FALSE'
|
Antibiotic
|
05/26/2005
|
Focalin XR Extended-Release Capsules
|
dexmethylphenidate
|
Treatment of Attention-Deficit Hyperactivity Disorder in children 6 years of age and older
|
Should not be used in children under 6 years of age Effectiveness in patients age 6 years of age and older was established in clinical studies PK studies also conducted Long-term effects in children have not been established New dosage form
|
Labeling
|
|
P
|
|
|
Novartis
|
|
FALSE'
|
CNS Stimulant
|
06/21/2005
|
Keppra
|
levetiracetam
|
Adjunctive therapy in the treatment of partial onset seizures in patients with epilepsy
|
Extended indication from adults to patients 4 years and older Safety and effectiveness have not been established in patients less than 4 years of age PK analysis showed that clearance increased with an increase in body weight Approximately 22% increase of apparent total body clearance of levetiracetam when co-administered with enzyme-inducing Anti-Epileptic Drugs (AEDs). Dose adjustment not necessary 37.6% of pediatric patients reported behavioral symptoms compared to 13.3% in adults Somnolence occurred in 22.8% in pediatric patients compared to 14.8% in adults Information on dose, PK parameters, AE profile and clinical studies
|
Labeling
|
B
|
|
|
|
UCB Pharma
|
06/03/2008
|
FALSE'
|
Anticonvulsant
|
06/29/2005
|
Topamax Tablets and Sprinkle Capsules
|
topiramate
|
Initial monotherapy for partial onset or primary generalized tonic-clonic seizures in children 10 years of age and older
|
Effectiveness established in studies of patients down to 6 years of age Use in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials Provides information regarding treatment-emergent decrease in serum bicarbonate and adverse events Some patients in the study discontinued therapy due to adverse events; however, adverse events associated with discontinuing therapy included difficulty with concentration/attention Studies waived in children 0-2 years of age; deferred in children 2-10 years of age New indication
|
Labeling
|
|
P
|
|
|
Johnson & Johnson
|
|
FALSE'
|
Anticonvulsant
|
07/21/2005
|
Adderall XR
|
amphetamines mixed salts
|
ADHD
|
Expanded labeling for 13-17 year olds On a mg/kg body weight basis children 6-12 years have a higher clearance than adolescents or adults. Body weight is the primary determinant There was not adequate evidence that doses greater than 20 mg/day conferred additional benefit in a placebo-controlled study conducted in adolescents aged 13-17 with ADHD In a single-dose PK study in adolescents, isolated increases in systolic blood pressure (SBP) were observed in patients receiving 10 mg and 20 mg Adderall XR. Higher single doses were associated with a greater increase in SBP Sustained increases in blood pressure should be treated with dose reduction and/or appropriate medication Information on dose, PK parameters, and AE profile
|
Labeling
|
|
|
B, P
|
|
Shire
|
10/28/2004
|
FALSE'
|
CNS Stimulant
|
07/27/2005
|
Singulair Oral Granules, Tablets, and Chewable Tablets
|
montelukast
|
Relief of symptoms of perennial allergic rhinitis in children 6 months of age and older
|
Effectiveness was extrapolated from a allergic rhinitis study in patients 15 years of age and older Safety in patients 6 to 23 months is supported by data from PK and safety and efficacy studies in asthma in this pediatric population and from adult PK studies Studies waived in children < 6 months of age New indication
|
Labeling
|
|
P
|
|
|
Merck
|
|
FALSE'
|
Antiasthmatic; antiallergy
|
07/29/2005
|
Avandia
|
rosiglitazone
|
Type 2 Diabetes Mellitus
|
Data are insufficient to recommend pediatric use of rosiglitazone In a 24 week double-blind controlled trial in children with type 2 diabetes mellitus, aged 10 to 17 years, with a baseline BMI of 33 kg/m2 were randomized to treatment with rosiglitazone or metformin Mean change from baseline in HbA1c was -0.14% with rosiglitazone and -0.49% with metformin There was an insufficient number of patients to establish statistically whether these observed mean treatment effects were similar or different Weight gain similar to that in adults Information on PK parameters, and AE profile
|
Labeling
|
B
|
|
|
|
SB Pharmco
|
12/09/2004
|
FALSE'
|
Antidiabetic
|
08/04/2005
|
Loperamide Hydrochloride Soft Gelatin Capsules
|
loperamide
|
Control symptoms of diarrhea in children 12 years of age and older
|
New dosage form; new dosing regimen No new clinical studies Bioequivalence study in adults compared the current OTC drug (Imodium caplet) and this drug Studies waived in children 0-2 years of age
|
Labeling
|
|
P
|
|
|
Banner Pharmacaps
|
|
TRUE'
|
Antidiarrheal
|
08/11/2005
|
Mobic
|
meloxicam
|
Relief of signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis
|
Safety and efficacy established in patients 2 years of age and older Clinical studies evaluated doses ranging from 0.125 mg/kg/day to 0.375 mg/kg/day. There was no additional benefit demonstrated by doses above 0.125 mg/kg/day in the clinical trials. The lowest effective dose should be used Adverse events in children were similar to those in adults including skin reactions and gastrointestinal bleed risk Information on dose, PK parameters, AE profile and clinical studies
|
Labeling
|
|
|
B, P
|
|
Boehringer Ingelheim
|
04/15/2005
|
FALSE'
|
Anti-inflammatory
|
09/13/2005
|
NovoLog
|
insulin aspart recombinant injection
|
Diabetes Mellitus
|
In clinical studies comparing NovoLog to regular human insulin in patients 2 to 18 years with type 1 diabetes, NovoLog achieved glycemic control comparable to regular human insulin The incidence of hypoglycemia was similar for both treatment groups
|
Labeling
|
B
|
|
|
|
Novo Nordisk
|
05/24/2005
|
FALSE'
|
Antidiabetic
|
09/28/2005
|
Emtriva
|
emtricitabine
|
HIV-1 infection in combination with other antiretroviral agents
|
Safety and effectiveness in pediatric patients 3 months and older supported by data from 3 open-label, nonrandomized clinical studies Safety and effectiveness in patients < 3 months have not been established Relative bioavailability of Emtriva oral solution is approximately 80% of Emtriva capsules. Thus, maximum dosage is different for these 2 formulations: Solution max - 240 mg once daily; Capsules max - children weighing > 33 kg one 200 mg capsule once daily The AE profile in pediatric patients was comparable to that observed in adults Information on dose, PK parameters, AE profile and clinical studies
|
Labeling
|
|
|
B, P
|
|
Gilead Sciences
|
05/24/2006
|
FALSE'
|
Antiviral
|
10/06/2005
|
Norvir
|
ritonavir
|
Treatment of HIV-infection in combination with other antiretroviral agents
|
Extended age range from 2 years down to 1 month AE profile in the pediatric population was similar to that for adults Information on dose and PK parameters
|
Labeling
|
B
|
|
|
|
Abbott
|
06/14/2005
|
FALSE'
|
Antiviral
|
10/19/2005
|
Levemir
|
insulin detemir [rDNA origin] injection
|
Type 1 diabetes
|
Summary is pending
|
Labeling
|
|
P
|
|
|
Novo Nordisk
|
|
|
Antidiabetic
|
10/28/2005
|
Trileptal
|
oxcarbazepine
|
Use as adjunctive therapy in children aged 2 years and above with epilepsy
|
Extended adjunctive therapy age range from 4 years down to 2 years No evidence drug was effective as adjunctive therapy in patients < 2 years In clinical studies as adjunctive therapy, apparent clearance (L/hr/kg) decreased when age increased such that children 2 to <4 years of age may require up to twice the dose per body weight compared to adults; and children 4 to d12 years of age may require a 50% higher dose per body weight compared to adults Approximately 11% of pediatric patients < 4 years discontinued treatment because of adverse events including convulsions, status epilepticus and ataxia Information on dose, PK parameters, AE profile and clinical studies
|
Labeling
|
B
|
|
|
|
Novartis
|
03/02/2005
|
FALSE'
|
Neurology
|
11/09/2005
|
Fluocinolone Acetonide Oil
|
fluocinolone
|
Chronic eczematous external otitis (outer ear) in children 2 years of age and older
|
Effectiveness established in studies of patients 2 years of age and older New indication
|
Labeling
|
|
P
|
|
|
Hill Dermaceuticals
|
|
FALSE'
|
Anti-inflammatory, topical
|
11/28/2005
|
Amaryl
|
glimepiride
|
Type-2 Diabetes Mellitus
|
Data are insufficient to recommend pediatric use of glimepiride In an active-controlled, single-blind, 24-week trial, 272 pediatric patients aged 8 to 17 years with Type 2 diabetes were randomized to treatment with glimepiride or metformin. Trial suggested differences favoring metformin AE profile in the pediatric population was similar to that for adults Information on PK parameters
|
Labeling
|
|
|
B, P
|
|
Aventis
|
06/09/2005
|
FALSE'
|
Antidiabetic
|
12/01/2005
|
Effexor XR Extended-Release Capsules
|
venlafaxine
|
Social anxiety disorder
|
Provided additional safety data for changes in weight, height, and appetite occurring in pediatric patient Information based on a clinical study of patients with SAD New indication (not approved in pediatric patients)
|
Labeling
|
|
P
|
|
|
Wyeth
|
|
FALSE'
|
Antidepressant
|
12/08/2005
|
Meridia
|
sibutramine
|
Obesity
|
The data are inadequate to recommend the use of sibutramine for the treatment of obesity in pediatric patients Efficacy in obese adolescents has not been adequately studied Sibutramine's mechanism of action inhibiting the reuptake of serotonin and norepinephrine is similar to that of some antidepressants It is unknown if sibutramine increases the risk of suicidal behavior or thinking in pediatric patients In a study of adolescents with obesity in which 368 patients were treated with sibutramine and 130 patients with placebo, one patient in each group attempted suicide. Suicidal ideation was reported by 2 sibutramine-treated patients and none of the placebo patients
|
Labeling
|
B
|
|
|
|
Abbott
|
10/06/2004
|
FALSE'
|
Obesity management
|
12/21/2005
|
Fosamax
|
alendronate
|
Severe osteogenesis imperfecta
|
Alendronate is not indicated for use in children The efficacy and safety were examined in a randomized, double-blind, placebo-controlled two-year study of 139 patients, 4-18 years old, with severe osteogenesis imperfecta Treatment with alendronate did not reduce the risk of fracture There were no statistically significant differences between the alendronate and placebo groups in reduction of bone pain Information on PK parameters, AE profile, and clinical studies
|
Labeling
|
B
|
|
|
|
Merck
|
04/28/2003
|
FALSE'
|
Bone density
|
12/21/2005
|
TamiFlu
|
oseltamivir
|
Prophylaxis in pediatric patients 1 year to <13 years of age
|
Information on postmarketing clinical study in patients 1 to 12 years
|
Labeling
|
|
P
|
|
|
Roche
|
|
FALSE'
|
Antiviral
|
02/01/2006
|
Clarinex-D 12 Hour Extended Release Tablets
|
desloratadine/pseudoephedrine
|
Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis in children 12 years of age and older
|
Approval based on two safety and effectiveness studies in patients down to 12 years of age Not an appropriate dosage form for use in pediatric patients below 12 years of age. Studies waived in children < 12 years of age New dosing regimen
|
Labeling
|
|
P
|
|
|
Schering
|
|
FALSE'
|
Antihistamine
|
02/03/2006
|
ProAir HFA Inhalation Aerosol
|
albuterol
|
Prevention of exercise-induced bronchospasm in children 12 years of age and older
|
Expands use from previously approved bronchospasm with reversible obstructive airway disease Effectiveness based on study in adults and adolescents Safety and effectiveness in pediatric patients below 12 years of age have not been established New indication
|
Labeling
|
|
P
|
|
|
IVAX
|
|
FALSE'
|
Antiasthmatic
|
02/16/2006
|
Vusion Ointment
|
miconazole
|
Adjunctive treatment of diaper dermatitis in children 4 weeks of age and older
|
Indicated for use in immunocompetent children Presence of candidal infection should be established by microscopic evaluation prior to initiating treatment Effectiveness based on three clinical studies in infants and toddlers Safety when used for more than 7 days is not known New active ingredient
|
Labeling
|
|
P
|
|
|
Barrier Therapeutics
|
|
FALSE'
|
Antifungal, topical
|
02/28/2006
|
Flovent HFA
|
fluticasone propionate
|
Asthma in 4 - 11 years
|
Flovent HFA should be administered by the orally inhaled route only in patients 4 years and older. Clinical studies were conducted in children with asthma 6 months to less than 4 years Information added to Pediatric Use
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Antiasthmatic
|
03/02/2006
|
Vanos Cream
|
fluocinonide
|
Relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in children 12 years of age and older
|
Use in pediatric patients younger than 12 years of age is not recommended Effectiveness extrapolated from adult studies Safety in patients 12 to 17 years of age was similar to that observed in adults Information provided on HPA axis suppression from safety studies with Vanos Cream in 4 cohorts of pediatric patients (3 months - 18 years of age) with atopic dermatitis Studies waived in children 0-11 years of age New indication
|
Labeling
|
|
P
|
|
|
Medicis
|
|
FALSE'
|
Anti-inflammatory, topical
|
03/16/2006
|
Avapro
|
irbesartan
|
Hypertension
|
In a study at a dose up to 4.5 mg/kg once daily, irbesartan did not appear to lower blood pressure effectively in pediatric patients ages 6 to 16 years
|
Labeling
|
B
|
|
|
|
Sanofi-Synthelabo
|
09/16/2004
|
FALSE'
|
Antihypertensive
|
03/29/2006
|
Relenza
|
zanamivir
|
Prevention of influenza in children 5 years of age and older
|
Safety and effectiveness for prophylaxis based on 4 clinical studies in patients 5-16 years of age No differences in safety and effectiveness were observed between pediatric and adult subjects. Dosing information provided Studies waived in children <5 years of age New indication
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Antiviral
|
04/06/2006
|
Daytrana
|
methylphenidate
|
ADHD
|
Summary is pending
|
Labeling
|
|
P
|
|
|
Shire
|
|
FALSE'
|
CNS Stimulant
|
04/10/2006
|
Lescol & Lescol XL
|
fluvastatin
|
Heterozygous familial hypercholesterolemia as an adjunct to diet
|
New indication in adolescent boys and girls (at least one year post-menarche) 10-16 years of age, with heterozygous familial hypercholesterolemia Information on dose, AE profile and clinical studies
|
Labeling
|
|
|
B, P
|
|
Novartis
|
12/15/2005
|
FALSE'
|
Antilipemic
|
04/27/2006
|
Genotropin Injection
|
somatropin (rDNA origin)
|
Long-term treatment of growth failure associated with Turner syndrome
|
Indicated for use in pediatric patients with open epiphyses Effectiveness and safety based on studies in pediatric patients New indication
|
Labeling
|
|
P
|
|
|
Pharmacia & Upjohn
|
|
FALSE'
|
Growth hormone
|
04/28/2006
|
Nexium
|
esomeprazole
|
Short-term treatment of GERD
|
Use in adolescent patients 12 to 17 years of age is supported by extrapolation from studies in adults, and safety and PK studies performed in adolescent patients Safety and effectiveness in patients < 12 years has not been established Safety and effectiveness for other pediatric uses have not been established Information on dose, treatment related AEs, clinical study
|
Labeling
|
B
|
|
|
|
AstraZeneca
|
05/01/2009
|
FALSE'
|
Antiulcerative
|
05/08/2006
|
Solodyn Extended-Release Tablets
|
minocycline
|
Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in children 12 years of age and older
|
Only used to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris Safety and effectiveness established from studies in patients 12 years of age and older Safety and effectiveness in pediatric patients below 12 years of age has not been established Studies waived in children 0-11 years of age New dosage form
|
Labeling
|
|
P
|
|
|
Medicis
|
|
FALSE'
|
Antibiotic
|
05/10/2006
|
Sandostatin LAR
|
octreotide
|
Weight loss due to hypothalamic obesity from cranial insult
|
A randomized double-blind, placebo-controlled study in 60 patients aged 6 17 years with hypothalamic obesity from cranial insult did not demonstrate efficacy and safety of octreotide as a weight loss agent; Mean BMI increased 0.1 kg/m2 in drug treated patients compared to 0.0 kg/m2 in control-treated patients No unexpected AEs were observed; However, the incidence of new cholelithiasis in this pediatric population (33%) was higher than that seen in adult indications Information on PK parameters and AEs
|
Labeling
|
B
|
|
|
|
Novartis
|
01/12/2006
|
FALSE'
|
Endocrine agent
|
06/29/2006
|
Lidocaine and Tetracaine Cream
|
lidocaine; tetracaine
|
Topical local analgesia for superficial dermatological procedures
|
Studies failed to show effectiveness over placebo in reducing the pain associated with venipuncture in pediatric patients 5-17 years of age New active ingredient
|
Labeling
|
|
P
|
|
|
ZARS
|
|
FALSE'
|
Anesthetic, topical
|
07/21/2006
|
Anthelios SX Cream
|
avobenzone; ecamsule; octocrylene
|
Prevention of sunburn and protection from UVA and UVB rays in children 6 months of age and older OTC
|
Effectiveness extrapolated from adult studies Safety studies included pediatric patients 6 months of age and older Age range based on monograph Deferred studies in children < 6 months of age New active ingredient
|
Labeling
|
|
P
|
|
|
LOreal USA
|
|
FALSE'
|
Sunscreen
|
07/21/2006
|
Symbicort Inhalation Aerosol
|
Formoterol / budesonide
|
Long-term maintenance treatment of asthma in children 12 years of age and older
|
Effectiveness and safety in patients 12 years of age and older established in studies up to 12 months long PK studies in patients 6-11 years of age Effectiveness in patients 6 to < 12 years of age has not been established Overall safety profile in patients 6 to < 12 years of age was similar to that observed in patients 12 years of age and older Studies waived in children 0-6 years of age; deferred in children 6-12 years of age New active ingredient
|
Labeling
|
|
P
|
|
|
AstraZeneca
|
|
FALSE'
|
Antiasthmatic
|
07/27/2006
|
Sodium Chloride Injection
|
sodium chloride
|
Use in flushing compatible contrast agents through IV administration sets into indwelling intravascular access devices
|
Safety of manual injection in pediatric patients is supported by reported clinical experience with IV infusion and flush safety and effectiveness of Sodium Chloride Injection, USP 0.9% administered by power injection in pediatric patients have not been established Administration to pediatric patients by power injection is not recommended To minimize the risk of fluid overload, the smallest dose necessary for manually flushing contrast agent through the vascular access line should be used Manual injection to pediatric patients should take into account the patient's weight, fluid status, and concomitant medical conditions to determine if use is appropriate New indication
|
Labeling
|
|
P
|
|
|
Tyco Healthcare
|
|
FALSE'
|
Hematology/Coagulation
|
07/28/2006
|
Xolegel Gel
|
ketoconazole
|
Treatment of seborrheic dermatitis in children 12 years of age and older
|
Effectiveness established from studies in patients 12 years of age and older Safety and effectiveness in pediatric patients below 12 years of age have not been establishedstudies waived in children 0-12 years of age New dosage form
|
Labeling
|
|
P
|
|
|
Barrier Therapeutics
|
|
FALSE'
|
Antifungal, topical
|
09/15/2006
|
Noxafil Oral Suspension
|
posaconazole
|
Prevention of invasive Aspergillis and Candida infections in patients 13 years of age and older
|
Information on PK and safety studies in patients 13-17 years of age Safety profile in patients 8-17 years of age similar to adults Safety and effectiveness in patients below 13 years of age have not been established Additional information on pharmacokinetics provided in patients down to 8 years of age Studies deferred in children 0-12 years of age New drug
|
Labeling
|
|
P
|
|
|
Schering
|
|
FALSE'
|
Antifungal
|
09/19/2006
|
Verdeso Foam
|
desonide
|
Treatment of mild to moderate atopic dermatitis in patients 3 months of age and older
|
Effectiveness established from studies in 581 pediatric patients 3 months to 17 years of age Effect on HPA axis function was investigated in pediatric patients 6 months to 17 years of age in one study of 75 patients Safety has not been evaluated in patients below 3 months of age Use for the minimum amount of time necessary due to the potential to suppress HPA axis treatment should not exceed 4 consecutive weeks New dosage form
|
Labeling
|
|
P
|
|
|
Connetics
|
|
FALSE'
|
Anti-inflammatory, topical
|
09/22/2006
|
Lamictal Tablets Lamictal Chewable Dispersible Tablets
|
lamotrigine
|
Adjunctive therapy for primary generalized tonic-clonic seizures in children 2 years of age and older
|
Effectiveness established in study with patients down to 2 years of age Revised boxed warning to remove restrictions on use in pediatric patients New indication
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Anticonvulsant
|
09/27/2006
|
Gleevec
|
imatinib mesylate
|
Treatment of newly diagnosed pediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
|
Extended age range for the treatment of newly diagnosed CML down to pediatric patients There are no data in children < 2 years of age Follow-up in children with newly diagnosed Ph+ chronic phase CML is limited Information on hematologic toxicities, AE profile, clinical studies and dosing guidelines new for newly diagnosed pediatric patients
|
Labeling
|
|
|
B, P
|
|
Novartis
|
06/09/2006
|
FALSE'
|
Antineoplastic
|
09/28/2006
|
Betaxon ophthalmic suspension
|
levobetaxolol
|
Elevated intraocular pressure
|
Extended indication from adults to pediatric patients The adverse event profile was comparable to that seen in adults and elderly patients
|
Labeling
|
|
|
B, P
|
|
Alcon
|
06/28/2006
|
FALSE'
|
Ophthalmologic hypotensive
|
09/28/2006
|
Azopt ophthalmic suspension
|
brinzolamide
|
Elevated intraocular pressure
|
IOP-lowering efficacy was not demonstrated in a 3-month controlled clinical study in which brinzolamide was dosed only twice a day in pediatric patients 4 weeks to 5 years of age
|
Labeling
|
B
|
|
|
|
Alcon
|
06/28/2006
|
FALSE'
|
Ophthalmologic hypotensive
|
09/29/2006
|
Fuzeon
|
enfuvirtide
|
HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy
|
Additional safety and efficacy data and AE information from clinical study in 5-16 year olds Insufficient data to provide dosing recommendations in patients < 6 years
|
Labeling
|
|
|
B, P
|
|
Hoffmann-La Roche
|
|
FALSE'
|
Antiviral
|
09/29/2006
|
DuraPrep Surgical Solution
|
iodine; isopropyl alcohol
|
Preoperative skin preparation for use in children 2 months of age and older OTC
|
Effectiveness based on determination that permeability of skin in children > 2 months of age is essentially that of adult skin Studies waived in children under 2 months of age for safety reasons and includes the following statement in the label: Do not use in children under 2 months of age due to excessive skin irritation and transient hypothyroidism. New active ingredient
|
Labeling
|
|
P
|
|
|
3M Health
|
|
FALSE'
|
Antiseptic
|
10/05/2006
|
UV Protective Suncare Capital Soleil 20 Anthelios 20 UV Expert 20
|
avobenzone; ecamsule; octocrylene; titanium
|
Prevention of sunburn and protection from UVA and UVB rays in children 6 months of age and older OTC
|
No clinical studies submitted to support Age range based on monograph Studies deferred in children under 6 months of age New active ingredient
|
Labeling
|
|
P
|
|
|
L'Oreal
|
|
FALSE'
|
Sunscreen
|
10/06/2006
|
Risperdal Tablets Risperdal Oral Solution Risperdal M-Tabs
|
risperidone
|
Treatment of irritability associated with autistic disorder in children 5 years of age and older
|
Effectiveness and safety established based on two 8 week studies in patients 5-16 years of age and one long-term study of 4-6 months Studies waived in children under 2 years of age due to difficulty to diagnose and treat this population New indicatiContraindicated in infants, small children, or any child who may be unable to swallow a capsule. Dosing information provided Information to monitor disease provided No clinical studies submitted New dosage form
|
Labeling
|
|
P
|
|
|
Janssen
|
|
FALSE'
|
Antipsychotic
|
10/13/2006
|
Tirosint capsules
|
levothyroxine
|
Replacement or supplemental therapy in hypothyroidism; treatment or prevention of euthyroid goiters
|
Contraindicated in infants, small children, or any child who may be unable to swallow a capsule. Dosing information provided Information to monitor disease provided No clinical studies submitted New dosage form
|
Labeling
|
|
P
|
|
|
Institute Biochimique SA
|
|
FALSE'
|
Thyroid replacement
|
10/16/2006
|
Allegra
|
fexofenadine
|
Seasonal allergic rhinitis (SAR) uncomplicated skin manifestations of chronic idiopathic urticaria (CIU)
|
New suspension developed Suspension indicated for the treatment of SAR in 2 11 years based on the PK comparisons in adult and pediatric patients and an extrapolation of efficacy in adults; Suspension indicated for the treatment of CIU in 6 months 11 years based on the PK comparisons in adults and children and an extrapolation of efficacy in adults Safety and effectiveness of suspension in pediatric patients under 6 months of age have not been established Additional information on dose, PK parameters, safety and AEs
|
Labeling
|
B
|
|
|
|
Aventis
|
01/27/2003
|
FALSE'
|
Antihistamine
|
10/19/2006
|
Zaditor ophthalmic solution
|
ketotifen
|
Temporary relief of itchy eyes in children 3 years of age and older OTC
|
No new studies submitted New indication
|
Labeling
|
|
P
|
|
|
Novartis
|
|
TRUE'
|
Antihistamine, topical
|
10/20/2006
|
Desonate Gel
|
desonide
|
Treatment of mild to moderate atopic dermatitis in children 3 months of age and older
|
Effectiveness established from two studies in patients 3 months to 18 years of age Not recommended for use in patients under 3 months of age Treatment should not exceed 4 consecutive weeks HPA axis suppression studied in patients 6 months of age to 6 years of age New dosage form
|
Labeling
|
|
P
|
|
|
Dow
|
|
FALSE'
|
Anti-inflammatory, topical
|
11/01/2006
|
Humatrope for injection
|
somatropin (rDNA origin)
|
Treatment of short stature or growth failure in children with short stature homeobox-containing gene (SHOX) deficiency
|
Effectiveness established from one 2-year study for SHOX in 52 pediatric patients Information on adverse events provided Dosing information provided New indication
|
Labeling
|
|
P
|
|
|
Lilly
|
|
FALSE'
|
Growth hormone
|
11/07/2006
|
Ziana Gel
|
clindamycin; tretinoin
|
Treatment of acne vulgaris in patients 12 years of age and older
|
Effectiveness and safety based on two studies in patients 12 years of age and older New active ingredient
|
Labeling
|
|
P
|
|
|
Dow
|
|
FALSE'
|
Antiacne, topical
|
12/15/2006
|
Suprane
|
desflurane
|
Safety study of 2 agents used for maintenance of anesthesia in non-intubated patients
|
Not indicated for maintenance of anesthesia in non-intubated pediatric patients In a clinical safety trial in patients 2 - 16 years, desflurane and isoflurane were compared for maintenance of anesthesia in non-intubated patients to assess the incidence of respiratory adverse events. Desflurane was associated with higher rates of coughing, laryngospasm and secretions with an overall rate of respiratory events of 39%. 5% of pediatric patients 2-16 years old exposed to desflurane, experienced severe laryngospasm The incidence of respiratory events was highest in children aged 2-6 years; therefore, similar studies in children under the age of 2 years were not initiated. Additional information on clinical studies and AEs
|
Labeling
|
B
|
|
|
|
Baxter
|
09/13/2006
|
FALSE'
|
Anesthetic agent
|
12/15/2006
|
Celebrex
|
celecoxib
|
Relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA)
|
New indication in 2 years and older Has not been studied in patients < 2 years, in patients with body weight < 10 kg, or in patients with active systemic features Celecoxib should be used only with caution in patients with systemic onset JRA due to the risk for serious adverse reactions including the risk of disseminated intravascular coagulation The long-term cardiovascular toxicity in children has not been evaluated; it is unknown if the long-term risk may be similar to that seen in adults New 50 mg capsule developed Information on adding contents of a capsule to applesauce. for patients with difficulty swallowing capsules Information on dose, clinical studies, PK parameters, AEs
|
Labeling
|
B
|
|
|
|
Pfizer
|
08/23/2006
|
FALSE'
|
Anti-inflammatory
|
12/20/2006
|
Colazal
|
balsalazide
|
Mildly to moderately active ulcerative colitis in patients 5 years of age and older
|
Extended indication from adults to patients 5 years and older Dosing can be initiated at either 6.75 or 2.25 g/day PK of balsalazide, and metabolites showed very large inter-patient variability similar to that seen in adults AEs were similar to those seen in adults
|
Labeling
|
|
|
B, P
|
|
Salix
|
08/23/2006
|
FALSE'
|
Gastroenterology
|
12/22/2006
|
Emtriva
|
emtricitabine
|
HIV-1 infection in combination with other antiretroviral agents
|
Efficacy in preventing or treating HIV in neonates to 3 month olds could not be determined after a PK study in 20 neonates born to HIV positive mothers Information on dose in 0-3 months, additional safety and PK parameters
|
Labeling
|
|
|
B, P
|
|
Gilead Sciences
|
05/24/2006
|
FALSE'
|
Antiviral
|
01/10/2007
|
Eloxatin
|
oxaliplatin
|
Solid tumors
|
The effectiveness of oxaliplatin in children has not been established No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors Information on clinical studies and AEs
|
Labeling
|
B
|
|
|
|
Sanofi-Aventis
|
09/27/2006
|
FALSE'
|
Antineoplastic
|
02/07/2007
|
Actiq
|
fentanyl
|
Treatment of breakthrough pain in opioid tolerant children
|
Safety and efficacy in patients below the age of 16 years was not established in a clinical trial of 15 patients 5 to 15 years Information on PK parameters and clinical studies
|
Labeling
|
|
|
B, P
|
|
Cephalon
|
|
FALSE'
|
Anesthetic agent
|
02/23/2007
|
Vyvanse Capsules
|
lisdexamfetamine
|
Treatment of ADHD in children 6 to 12 years of age
|
Effectiveness established in two studies of patients 6-12 years of age Long-term effectiveness of more than 4 weeks has not been established Studies waived in children 0-5 years of age and deferred in children 13-17 years of age New active ingredient
|
Labeling
|
|
P
|
|
|
New River
|
|
FALSE'
|
CNS Stimulant
|
02/23/2007
|
Coreg
|
carvedilol
|
Heart failure
|
Effectiveness has not been established in patients < 18 years In a double-blind trial of 161 children, 2 months to 17 years with chronic heart failure receiving standard background treatment, randomized to placebo or carvedilol, carvedilol demonstrated reduction of heart rate 4-6 beats per minute There was no significant effect of treatment on clinical outcomes after 8 months of follow-up AEs occurring in e 10% of patients treated with carvedilol included chest pain (17%), dizziness (13%), and dyspnea (11%)
|
Labeling
|
|
|
B, P
|
|
GlaxoSmithKline
|
11/08/2006
|
FALSE'
|
Antihypertensive
|
03/19/2007
|
Keppra Tablets/ Keppra Oral Solution
|
levetiracetam
|
Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in children 6 years of age and older with idiopathic generalized epilepsy
|
Safety and effectiveness established in study that included patients down to 4 years of age Pediatric dosing information added Studies waived in children 1 month to 2 years of age and deferred in children 2-6 years of age New indication
|
Labeling
|
|
P
|
|
|
UCB
|
|
FALSE'
|
Anticonvulsant
|
03/22/2007
|
Aldara
|
imiquimod
|
Molluscum contagiosum
|
Efficacy in patients 2 12 years for the treatment of molluscum contagiosum was not demonstrated in two clinical trials in 702 patients Information on clinical studies and AEs
|
Labeling
|
B
|
|
|
|
Graceway Pharmaceuticals
|
12/13/2006
|
FALSE'
|
Topical
|
03/28/2007
|
Ambien
|
zolpidem
|
Insomnia associated with ADHD
|
Safety and effectiveness have not been established in pediatric patients with insomnia associated with ADHD In an 8-week controlled study in 201 pediatric patients 6-17 years, psychiatric and nervous system disorders comprised > 5% of treatment emergent adverse events, including dizziness (23.5%) headache (12.5%) and hallucinations (7.4%); treatment was discontinued due to an adverse event in 7.4%
|
Labeling
|
B
|
|
|
|
Sanofi Aventis
|
11/20/2006
|
FALSE'
|
Hypnotic
|
04/12/2007
|
Altabax Ointment 1%
|
retapamulin
|
Treatment of impetigo in patients 9 months of age and older
|
Safety and effectiveness established in studies that included 588 pediatric patients from 9 months of age to 17 years of age Studies waived in children 0-2 months of age and deferred in children 2-9 months of age New active ingredient
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Antibiotic, topical
|
04/19/2007
|
Valtropin
|
somatropin (rDNA origin)
|
Short stature in children with Turner Syndrome
|
Summary is pending
|
Labeling
|
|
P
|
|
|
LG Life
|
|
FALSE'
|
Growth hormone
|
04/27/2007
|
Azasite Ophthalmic Solution 1%
|
azithromycin
|
Treatment of bacterial conjunctivitis caused by certain microorganisms in patients down to 1 year of age
|
Effectiveness and safety were established in controlled clinical trials including patients down to 1 years of age Dosing information provided New dosage form
|
Labeling
|
|
P
|
|
|
InSite Vision
|
|
FALSE'
|
Antibiotic
|
04/27/2007
|
Veramyst
|
fluticasone furoate
|
Treatment of the symptoms of seasonal and perennial allergic rhinitis
|
Approved in patients 2 years and older Controlled clinical trials included 1,224 patients 2 - 11 years and 344 adolescent patients 12 to 17 yearsThe safety and effectiveness in children < 2 years have not been establishedInformation on clinical trials, dosing, and adverse reactionsNew drug
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Anti-inflammatory, topical
|
05/18/2007
|
Locoid Lotion 0.1%
|
hydrocortisone butyrate
|
Treatment of mild to moderate atopic dermatitis in children 3 months of age and older
|
Effectiveness established in one study of 284 patients from 3 months to 18 years of age Information provided on HPA axis suppression from one safety study with Locoid Lotion of 84 pediatric patients from 3 months to 18 years of age with moderate to severe atopic dermatitis affecting at least 25% of body surface area Studies waived in children < 3 months of age New dosage form
|
Labeling
|
|
P
|
|
|
Ferndale Labs
|
|
FALSE'
|
Anti-inflammatory, topical
|
05/25/2007
|
Xyzal Tablets 5 mg
|
levocetirizine
|
Relief of symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis in adults and children 6 years of age or older, and for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age or older
|
Summary is pending
|
Labeling
|
|
P
|
|
|
UCB
|
|
FALSE'
|
Antihistamine
|
05/30/2007
|
Zyflo CR Extended Release Tablets
|
zileuton
|
Prevention and chronic treatment of asthma in children 12 years of age and older
|
Should not be used in children under 12 years of age Effectiveness was established in clinical studies that included pediatric patients 12 years of age and older Short-term and long-term safety were established in clinical studies that included pediatric patients 12 years of age and older Studies waived in children 0-4 years of age and deferred in children 5-11 years of age New dosage form
|
Labeling
|
|
P
|
|
|
Critical Therapeutics
|
|
FALSE'
|
Antiasthmatic
|
06/08/2007
|
Betoptic S
|
betaxolol
|
Elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension
|
Extended indication from adults to pediatric patients The adverse reaction profile was comparable to that seen in adults
|
Labeling
|
B
|
|
|
|
Alcon
|
02/28/2007
|
FALSE'
|
Ophthalmologic hypotensive
|
06/08/2007
|
Timolol GFS
|
timolol
|
Elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension
|
Extended indication from adults to pediatric patients The adverse reaction profile was comparable to that seen in adults
|
Labeling
|
B
|
|
|
|
Falcon Pharmaceuticals
|
02/28/2007
|
FALSE'
|
Ophthalmologic hypotensive
|
06/12/2007
|
Extina Foam, 2%
|
ketoconazole
|
Topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older
|
Effectiveness and safety were established in a clinical study that included 44 patients from 12-17 years of age Studies waived in children 0-12 years of age New dosage form
|
Labeling
|
|
P
|
|
|
Stiefel Laboratories
|
|
FALSE'
|
Antifungal, topical
|
06/14/2007
|
Lexiva Oral Suspension
|
fosamprenavir
|
Treatment of HIV infection in patients 2-18 years of age
|
Effectiveness and safety were established in two clinical studies of pediatric patients 2-18 years of age Adverse event profile is similar to that of adults with the exception of vomiting, which, regardless of causality, occurred more frequently among pediatric patients Dosing information provided Studies waived in children 0-1 month of age and deferred in children 1 month - 2 years of age New dosage form
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Antiviral
|
07/18/2007
|
Toprol XL
|
metoprolol
|
Hypertension
|
A study in 144 pediatric hypertensive pediatric patients aged 6 - 16 years did not meet its primary endpoint. However, some study endpoints demonstrated effectiveness Adverse event profile similar to adults Safety and effectiveness have not been established in patients < 6 years of age Information on PK parameters, clinical studies, and dose
|
Labeling
|
B
|
|
|
|
AstraZeneca
|
07/27/2006
|
FALSE'
|
Antihypertensive
|
08/16/2007
|
Zingo
|
lidocaine
|
Topical local analgesia prior to venipuncture or peripheral intravenous cannulation in children 3-18 years of age
|
Summary is pending
|
|
|
P
|
|
|
Anesiva
|
|
FALSE'
|
Anesthetic, topical
|
08/17/2007
|
Provigil
|
modafinil
|
Narcolepsy
|
Modafinil is not approved for use in pediatric patients for any indication Safety and effectiveness were not demonstrated in a controlled 6-week study in 165 pediatric patients 5-17 years with narcolepsy Serious rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with the use of modafinil In the controlled and open-label clinical studies, treatment emergent adverse events of the psychiatric and nervous system included Tourettes syndrome, insomnia, hostility, increased cataplexy, increased hypnagogic hallucinations and suicidal ideation Information on safety, AEs and clinical study
|
Labeling
|
B
|
|
|
|
Cephalon, Inc
|
03/21/2006
|
FALSE'
|
CNS Stimulant
|
08/22/2007
|
Risperdal
|
risperidone
|
Schizophrenia; short-term treatment of acute manic or mixed Episodes associated with Bipolar I Disorder
|
Extended schizophrenia indication from adults to adolescents 1317 years; extended bipolar mania indication from adults to children and adolescents 10-17 years Safety and effectiveness in children < 13 years of age with schizophrenia have not been established; safety and effectiveness in children < 10 years of age with bipolar mania have not been established No additional benefit was seen above 3 mg/day in schizophrenia studies and 2.5 mg/day in the Bipolar mania study; higher doses were associated with more adverse events. Doses higher than 6 mg/day have not been studied. Information on dose, clinical studies, AE profile
|
Labeling
|
B
|
|
|
|
Johnson & Johnson
|
02/28/2007
|
FALSE'
|
Antipsychotic
|
09/11/2007
|
Levaquin
|
levofloxacin
|
Community-acquired pneumonia
|
Levofloxacin is not indicated for pediatric patients < 18 years of age In a prospective, long-term, surveillance study, levofloxacin treated children had a significantly higher incidence of musculoskeletal (MS) disorders (arthralgia, arthritis, tendonopathy, and gait abnormality) compared to non-fluoroquinolone-treated children Information on clinical studies, AE profile
|
Labeling
|
|
|
B, P
|
|
Ortho-McNeil
|
03/14/2007
|
FALSE'
|
Antibiotic
|
09/20/2007
|
Norditropin Cartridges
|
somatropin (rDNA origin)
|
Treatment of short stature in children with Turner syndrome
|
Safety and effectiveness based on studies in pediatric patients New Warning: Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear and hearing disorders. Somatropin treatment may increase the occurrence of otitis media in patients with Turner syndrome. In addition, patients with Turner syndrome should be monitored closely for cardiovascular disorders (e.g., stroke, aortic aneurysm/dissection, hypertension) as these patients are also at risk for these conditions Information on recommended dosing, adverse events (AEs) and clinical studies New indication
|
Labeling
|
|
P
|
|
|
Novo Nordisk
|
|
FALSE'
|
Growth hormone
|
09/28/2007
|
Lamisil Oral Granules
|
terbinafine
|
Tinea capitis
|
New indication in 4 years and older Two randomized safety and efficacy trials were conducted in patients 4 to 12 years old with tinea capitis. Terbinafine was dosed on a mg/kg basis and treated for 6 weeks Although no hepatotoxicity was seen during trials, pre-treatment serum transaminases tests are advised. The most common adverse events observed in the trials were nasopharyngitis, headache, pyrexia, cough, vomiting, and upper respiratory tract infection New 125 mg and 187.5 mg oral granule formulations developed; take with food Information on dose, PK parameters, AE profile, and instructions for use
|
Labeling
|
B
|
|
|
|
Novartis
|
12/04/2006
|
FALSE'
|
Antifungal, topical
|
10/29/2007
|
Abilify
|
aripiprazole
|
Schizophrenia
|
Extended schizophrenia indication from adults to adolescents 1317 years Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated In 6-week placebo controlled efficacy trial in patients 13 17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship Information on dose, AEs, clinical studies
|
Labeling
|
B
|
|
|
|
Otsuka
|
11/14/2007
|
FALSE'
|
Antipsychotic
|
10/30/2007
|
Combigan 0.2%/0.5% ophthalmic solution
|
brimonidine tartrate/timolol maleate
|
Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension
|
Safety and effectiveness supported by evidence from clinical studies in adults with additional data from a study in children with glaucoma ages 2 7 years old Not recommended for use in children under the age of 2 years due to safety concerns based on reports of apnea, bradycardia, hypotension, hypothermia, hypotonia, and somnolence in infants Safety and effectiveness have not been studied in children below the age of two years New active ingredient
|
Labeling
|
|
P
|
|
|
Allergan
|
|
TRUE'
|
Ophthalmologic hypotensive
|
11/09/2007
|
Kaletra Oral Solution, 80 mg/20 mg & Kaletra (1opinavir/ritonavir) Tablets, 200 mg/50 mg
|
lopinavir/ ritonavir
|
HIV -1 protease inibitor indicated in combination with other antiretroviral agents for the treatment of HIV -1 infection.
|
Dosing and administration information provided for children Use of a lower strength tablet in a twice daily dosing regimen for pediatric patients weighing greater than 15 kg New dosing regimen
|
Labeling
|
|
P
|
|
|
Abbott Laboratories
|
|
TRUE'
|
Antiviral
|
11/21/2007
|
Omnaris Nasal Spray
|
ciclesonide
|
Treatment of seasonal allergic rhinitis (SAR) in patients 6 through less than 12 years of age
|
Indication extended down to 6 years of age Pediatric dosing information provided Two clinical studies evaluated safety in children 6 to 11 years of age and the overall incidence of adverse events was comparable to those treated with placebo Efficacy in children 2 to 5 years of age was not established in clinical trials conducted in this age group. Waiver of studies in children ages 0 to less than 2 years of age for SAR because of local and systemic safety concerns as well as lack of disease and/or diagnosis difficulties in children New indication
|
Labeling
|
|
P
|
|
|
Nycomed US Inc.
|
|
FALSE'
|
Antiasthmatic; antiallergy
|
11/29/2007
|
Triesence 40mg/mL
|
triamcinolone acetonide injectable suspension
|
Visualization during vitrectomy
|
Efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations Adverse effects of corticosteroids in pediatric patients are similar to those in adults New indication
|
Labeling
|
|
P
|
|
|
Alcon Research, Ltd.
|
|
TRUE'
|
Anti-inflammatory, topical
|
11/29/2007
|
Diovan
|
valsartan
|
Hypertension
|
Labeling for 6-16 years of age Not recommended for pediatric patients less than 6 years due to safety findings possibly related to treatment or with glomerular filtration rate < 30mL/min/1.73m2 Information on dose, clinical studies in 1-16 years and pharmacokinetics No relevant differences were identified between adverse experience profile for pediatric patients and that previously reported for adult patients Information on preparation of a suspension
|
Labeling
|
B
|
|
|
|
Novartis
|
08/08/2007
|
FALSE'
|
Antihypertensive
|
12/12/2007
|
Derma-Smoothe/FS Topical Oil
|
fluocinolone
|
Treatment of atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks
|
Extended age range down to 3 months Effectiveness and safety are not established in children less than 3 months old Safety was evaluated in two pediatric clinical studies (including facial use) Pediatric dosing and administration information provided Studies waived in children under 3 months of age due to safety concerns of adrenal suppression New indication
|
|
|
P
|
|
|
Hill
|
|
FALSE'
|
Anti-inflammatory, topical
|
12/13/2007
|
Kuvan
|
sapropterin dihydrochloride
|
Treatment to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU)
|
*Pediatric patients with PKU, ages 4 to 16 years, have been treated with Kuvan in clinical studies. *Safety and efficacy of Kuvan in pediatric patients less than 4 years of age have not been assessed in clinical studies. Frequent blood monitoring is recommended in the pediatric population to ensure adequate blood Phe level control.
|
|
B
|
|
|
|
BioMarin Pharmaceutical Inc.
|
|
FALSE
|
|
12/19/2007
|
Hepsera
|
adefovir dipivoxil
|
Chronic hepatitis B virus infection
|
Extended indication from adults to pediatric patients 12 years and older Not recommended for children <12 years of age. Efficacy was not significantly different from placebo in a clinical study in children <12 years Safety e12 < 18 years was similar to that observed in adults Information on PK, AEs, clinical study, clinical resistance
|
Labeling
|
|
|
B, P
|
|
Gilead
|
|
FALSE'
|
Antiviral
|
12/27/2007
|
AndroGel
|
testosterone
|
Use in adolescent boys with delayed puberty
|
Safety and efficacy in males < 18 years old have not been established Improper use may result in acceleration of bone age and premature closure of epiphyses
|
Labeling
|
B
|
|
|
|
Unimed
|
08/22/2007
|
FALSE'
|
Androgen-anabolic steroid
|
12/27/2007
|
Voluven
|
6% Hydroxyethyl Starch 130/0.4 In 0.9% Sodium Chloride Injection
|
Plasma volume substitute for treatment and prophylaxis of hypovolemia
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Fresenius Kabi Norge AS
|
|
FALSE'
|
Coagulant
|
01/02/2008
|
EVICEL
|
Fibrin Sealant (Human)
|
Adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Johnson/Johnson Wound Management
|
|
FALSE'
|
Coagulant
|
01/10/2008
|
Alvesco Inhalation Aerosol, 80 mcg & 160 mcg
|
ciclesonide
|
Treatment of asthma in patients 12 years of age and older.
|
Not indicated for children under the age of 12 years Five clinical studies evaluated safety in children 12 years of age and older Safety and effectiveness have not been established in children under 12 years of age Waiver of studies in children 0 to less than 6 months of age due to too few patients with the disease New dosage form
|
Labeling
|
|
P
|
|
|
Nycomed US Inc.
|
|
FALSE'
|
Antiasthmatic
|
01/17/2008
|
TamiFlu
|
oseltamivir
|
Safety information resulting from studies that established treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older
|
Influenza can be associated with a variety of neurologic and behavioral symptoms which can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. These events have been reported in patients receiving oseltamivir, primarily among pediatric patients, appear to be uncommon, and often had an abrupt onset and rapid resolution If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient
|
Labeling
|
B
|
|
|
|
Roche
|
03/22/2004
|
TRUE'
|
Antiviral
|
01/23/2008
|
Moxatag
|
amoxicillin
|
Use for tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes patients 12 years of age and older
|
Safety and effectiveness in pediatric patients younger than 12 years have not been established One clinical study evaluated safety and effectiveness in pediatric patients 12 years of age and older with no significant differences in treatment response or adverse reactions between adults and children A prospective study of 51 children suggested that overdosages of less than 250 mg/kg are not associated with significant clinical symptoms and do not require gastric emptying Waiver of studies in children ages 0 to less than two years because too few children have the disease New dosage form
|
Labeling
|
|
P
|
|
|
Middlebrook Pharmaceuticals
|
|
FALSE'
|
Antibiotic
|
01/28/2008
|
Xyzal 0.5 mg/mL Oral Solution
|
levocetirizine dihydrochloride
|
Relief of symptoms associated with seasonal and perennial allergic rhinitis (SAR and PAR) and treatment of uncomplicated skin manifestations of chronic idiopathic urticaria (CIU)
|
Dosing information provided Studies waived in children less than 6 months of age with PAR and CIU Waived in children less than 2 years of age with SAR New dosage form pediatric
|
Labeling
|
|
P
|
|
|
UCB
|
|
TRUE'
|
Antihistamine
|
01/31/2008
|
Inspra
|
eplerenone
|
Hypertension
|
Effectiveness was not established in a study of 304 hypertensive pediatric patients 4 - 17 years; eplerenone, at doses up to 100 mg/ day, did not lower blood pressure effectively Therefore, it has not been studied in hypertensive patients <4 years old Eplerenone has not been studied in hypertensive patients < 4 years or in pediatric patients with heart failure Adverse events similar to that of adults
|
Labeling
|
|
|
B, P
|
|
Pfizer
|
10/24/2007
|
FALSE'
|
Antihypertensive
|
02/01/2008
|
Asmanex Twisthaler 110mcg inhalation powder
|
mometasone furoate
|
Maintenance treatment of asthma as prophylactic therapy in children 4 years of age and older
|
Not indicated for relief of acute bronchospasm or in children less than 4 years of age Clinical studies, including 52 week safety trial conducted in children 4 11 years of age Pediatric dosing information provided Child may not get the most benefit for 1 to 2 weeks or longer after starting treatment New dosage form
|
Labeling
|
|
P
|
|
|
Schering Corporation
|
|
FALSE'
|
Antiasthmatic
|
02/21/2008
|
Humira
|
adalimumab
|
Treatment of juvenile idiopathic arthritis
|
Indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA)in patients 4 years of age and older Has not been studied in children <4 years of age; there are limited data on treatment in children with weight <15 kg Safety and efficacy in pediatric patients for uses other than JIA have not been established Adalimumab was studied in 171 patients 4 - 17 years with polyarticular JIA. AEs were generally similar to those seen in adults. 45% of children experienced an infection while receiving adalimumab with or without concomitant MTX in the first 16 weeks of treatment. Serious infections were observed in 4% of patients within approximately 2 years of initiation of treatment Information on dose, AEs, lab abnormalities, PK parameters, immunogenicity, immunization needs and clinical study New indication
|
Labeling
|
|
P
|
|
|
Abbott
|
|
FALSE'
|
Anti-inflammatory
|
02/27/2008
|
Abilify
|
aripiprazole
|
Bipolar I Disorder
|
Extended treatment of acute Bipolar Disorder indication from adults to pediatrics 1017 years The efficacy for the maintenance treatment of Bipolar Disorder in the pediatric population has not been evaluated The recommended target dose in Bipolar Disorder is 10 mg/day. In the study of pediatric patients 10 17 years with Bipolar Mania, 4 common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder, somnolence, akathisia and salivary hypersecretion Information on dose, AEs, clinical studies
|
Labeling
|
|
|
B, P
|
|
Otsuka
|
11/14/2007
|
FALSE'
|
Antipsychotic
|
02/27/2008
|
Nexium
|
esomeprazole
|
Short-term treatment of GERD
|
Expanded age range to include pediatric patients 1-11 years. Previously approved in 12-17 years Use in pediatric patients 1 to 17 years of age is supported by extrapolation from studies in adults, and safety and PK studies performed in pediatric and adolescent patients Safety and effectiveness in pediatric patients <1 year of age have not been established Safety and effectiveness for other pediatric uses have not been established Information on dose, treatment related adverse events (AEs), clinical study New formulation
|
Labeling
|
B
|
|
|
|
AstraZeneca
|
05/01/2009
|
FALSE'
|
Antiulcerative
|
03/12/2008
|
DAPTACEL
|
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
|
Active immunization as a booster dose against diphtheria, tetanus & pertussis
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Sanofi Pasteur
|
|
FALSE'
|
Preventive Vaccine
|
03/14/2008
|
NovoLog
|
insulin aspart [rDNA origin] injection
|
Insulin analog indicated to improve glycemic control
|
Efficacy was demonstrated in a clinical study with pediatric patients ages 4 to 18 years using an external insulin pump New dosing regimen
|
Labeling
|
|
P
|
|
|
Novo Nordisk
|
|
FALSE'
|
Antidiabetic
|
03/19/2008
|
ARTISS
|
Fibrin Sealant (Human)
|
To adhere autologous skin grafts to surgically prepared wound beds resulting from burns
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Baxter
|
|
FALSE'
|
Wound healing
|
03/20/2008
|
Zometa
|
zoledronic acid
|
Severe osteogenesis imperfecta
|
Zoledronic acid is not indicated for use in children Safety and effectiveness was studied in 152 pediatric patients with severe osteogenesis imperfecta aged 1 - 17 years. At one year, increases in BMD were observed in the zoledronic acid treatment group but the changes did not necessarily correlate with the risk for fracture or the incidence or severity of chronic bone pain Information on PK, clinical study, and AE profile
|
Labeling
|
B
|
|
|
|
Novartis
|
12/21/2007
|
FALSE'
|
Bone density
|
03/20/2008
|
Prilosec
|
omeprazole
|
Maintenance healing of erosive esophagitis
|
Efficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. Safety and effectiveness in children less than 1 year of age have not been established Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. New dosage form
|
Labeling
|
|
|
B, P
|
|
AstraZeneca
|
05/01/2001
|
FALSE'
|
Antiulcerative
|
03/24/2008
|
Depakote ER Depakote Sprinkles
|
divalproex disodium
|
Pediatric Bipolar Disorder; Prophylaxis of Migraine
|
Efficacy was not established in a double-blind, placebo controlled study of patients 10-17 years conducted to evaluate efficacy in the treatment of pediatric bipolar disorder Efficacy was not established in a double-blind, placebo-controlled study of patients 12 17 years conducted to evaluate the efficacy in the prophylaxis of migraine The safety and tolerability was similar to adults in 5 long-term safety studies Additional information on clinical studies, AE profile in Depakote ER labeling
|
Labeling
|
|
|
B, P
|
|
Abbott
|
12/14/2007
|
FALSE'
|
Anticonvulsant; Mood Stablizer
|
03/25/2008
|
Reyataz
|
atazanavir
|
HIV in 6 years and older
|
Extended indication from adults to children 6 years and older The safety, activity, and pharmacokinetic profiles in pediatric patients ages 3 months to < 6 years have not been established. Atazanavir should not be administered to pediatric patients below the age of 3 months due to the risk of kernicterus Dosing is based on body weight or body surface area not to exceed adult dose Adverse events (AEs) are generally similar to those seen in adults Information on dose, AEs, PK parameters, lab abnormalities, and clinical study
|
Labeling
|
|
|
B, P
|
|
Bristol-Myers Squibb
|
|
FALSE'
|
Antiviral
|
03/26/2008
|
Ventolin HFA
|
albuterol
|
Treatment of symptoms of bronchospasm associated with obstructive airway disease
|
Safety and effectiveness of albuterol administered with or without a spacer device in children < 4 years of age has not been demonstrated 3 randomized, double-blind, placebo-controlled studies in 250 children < 4 years, in which efficacy was not demonstrated, suggest that either the optimal dose has not been defined in this age-group or the drug is not effective in this age-group Information on clinical studies
|
Labeling
|
B
|
|
|
|
GlaxoSmithKline
|
08/27/2008
|
FALSE'
|
Antiasthmatic
|
03/31/2008
|
Lancôme UV Expert 40 La Roche-Posay Anthelios 40 Vichy Capital Soleil 40
|
avobenzone, ecamsule, octocrylene, titanium dioxide cream
|
Sunscreen OTC
|
Effectiveness extrapolated from adult studies Safety studies included pediatric patients 6 months of age and older Age range based on standards established in over-the counter monograph for sunscreens New active ingredient
|
|
|
P
|
|
|
LOreal USA
|
|
FALSE'
|
Sunscreen
|
04/03/2008
|
ROTARIX
|
Rotavirus Vaccine, Live, Oral
|
Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9)
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline Biologicals
|
|
FALSE'
|
Preventive Vaccine
|
04/07/2008
|
Orencia
|
abatacept
|
Moderate to severe polyarticular juvenile idiopathic arthritis
|
Indicated for reducing signs and symptoms in pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) ages 6 years and older. The safety and effectiveness in pediatric patients < 6 years of age and in pediatric patients for uses other than JIA have not been established Abatacept was studied in 190 patients 6 - 17 years with polyarticular JIA. AEs were generally similar to those seen in adults. Overall frequency of adverse events in the 4-month, lead-in, open-label period of the study was 70%; infections occurred at a frequency of 36%. A total of 6 serious adverse events were reported during the initial 4 months of treatment with abatacept. Information on dosing, PK, immunogenicity, immunization needs, AEs, and clinical study New indication
|
|
|
P
|
|
|
Bristol-Myers Squibb
|
|
FALSE'
|
Anti-inflammatory
|
04/15/2008
|
Patanase Nasal Spray
|
olopatadine hydrochloride
|
Relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older
|
Safety and effectiveness in children below the age of 12 years have not been established Symptoms of antihistamine overdose in children may initially include agitation and restlessness followed by drowsiness Efficacy and safety were evaluated in 3 clinical trials of 2 weeks duration in adult and adolescent patients, 12 years of age and older, with symptoms of SAR Dosage and administration information provided for children 12 years and older New indication, dosage form, dosing regimen, and route of administration
|
Labeling
|
|
P
|
|
|
Alcon Research, Ltd.
|
|
FALSE'
|
Antihistamine
|
04/30/2008
|
Cardiolite
|
technetium tc99m sestamibi
|
Medical imaging in Kawasaki disease
|
Safety and effectiveness have not been established in the pediatric population No evidence of diagnostic efficacy or clinical utility of scan was found in 3 clinical studies of children and adolescents with Kawasaki disease A study of 445 pediatric patients failed to demonstrate the predictive value of Cardiolite rest and stress myocardial perfusion imaging to define children with Kawasaki disease at risk of developing cardiac events 6 months after receiving Cardiolite; only 3cardiac events were observed. In all 3 cases, the scan was negative Adverse events similar to that of adults Information on dose, PK, and clinical studies
|
Labeling
|
|
|
B, P
|
|
Lantheus Medical Imaging
|
01/11/2008
|
FALSE'
|
Diagnostic aid
|
05/05/2008
|
Levaquin Tablets, 250 mg, 500 mg, and 750 mg Levaquin Oral Solution, 25 mg/mL Levaquin Injection and Levaquin Injection, 5 mg/mL
|
levofloxacin levofloxacin in 5% dextrose injection
|
Reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis (inhalational anthrax post-exposure)
|
New indication Dosing information provided for children less than and greater than 50 kg Efficacy is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit, and animal studies were used to evaluate survival; the product has not been tested in humans for the post-exposure prevention of inhalation anthrax Safety in pediatric patients treated for more than 14 days has not been studied Long-term safety data, including effects on cartilage, following administration in pediatric patients is limited Due to possible side effects, use is not recommended for pediatric patients except in the prevention of anthrax after inhalational exposure Pharmacokinetics were investigated in pediatric patients 6 months to 16 years old
|
|
|
P
|
|
|
Ortho-McNeil-Janssen Pharmaceutical, Inc.
|
|
TRUE'
|
Antibiotic
|
05/05/2008
|
Argatroban
|
argatroban
|
Heparin-Induced Thrombocytopenia (HIT) or HIT with Thrombosis
|
Safety and effectiveness, including the appropriate anticoagulation goals and duration of therapy, have not been established in pediatric patients Population PK/PD analysis of sparse data in 15 seriously ill pediatric patients ages <6 months 16 years diagnosed with HIT or suspected HIT requiring an alternative to heparin anticoagulation showed clearance in pediatric patients was 50% lower compared to healthy adults and led to dose recommendations Information on dose, AEs and PK
|
Labeling
|
|
|
B, P
|
|
Encysive
|
|
FALSE'
|
Hematology/Coagulation
|
05/08/2008
|
Desmopressin acetate Tablets, 0.1 mg and 0.2 mg
|
desmopressin acetate
|
Determine the capacity of the kidney to concentrate urine in pediatric patients (Renal Concentration Capacity Test or RCCT) and management of primary nocturnal enuresis (PNE)
|
Efficacy in RCCT was evaluated in a single trial with children 3 to 18 years old Three studies evaluated efficacy in children 5 to 17 years old with PNE; an additional study evaluated efficacy in adolescents 12 to 17 years old Fluid intake should be adjusted downward in children to decrease the potential occurrence of water intoxication and hyponatremia Dosing information provided for children 3 to 18 years old for RCCT Dosing information provided for pediatric patients 6 years of age and older with PNE Tablet dosage and administration information provided for children with central diabetes insipidus Pharmacokinetics and pharmacodynamics were evaluated in children New indications and dosing regimen
|
|
|
P
|
|
|
Ferring
|
|
FALSE'
|
Urology
|
05/09/2008
|
OraVerse Injection 0.4 mg (0.235 mg/mL)
|
phentolamine mesylate
|
Reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor
|
Use in children less than 6 years of age or weighing less than 15 kg (33 lbs) is not recommended Dosing information provided for children weighing 15 to 30 kg (66 lbs) Safety and efficacy were established in 2 clinical trials in children 12 to 17 years old, one trial in children ages 6 to 11 years, as well as adult studies Safety has been evaluated in pediatric patients under the age of 6 years but not efficacy Pharmacokinetics have been evaluated in children weighing 15 kg or more New indication
|
|
|
P
|
|
|
Novalar Pharmaceuticals, Inc.
|
|
FALSE'
|
Anesthetic, topical
|
06/05/2008
|
Zetia and Vytorin
|
ezetimibe and ezetimibe/ simvastatin
|
Heterozygous familial hypercholesterolemia as an adjunct to diet
|
The effects of ezetimibe co-administered with simvastatin compared to simvastatin monotherapy have been evaluated in adolescent boys and girls with heterozygous familial hypercholesterolemia (HeFH)
|
Labeling
|
|
|
B, P
|
|
MSP Singapore
|
02/14/2008
|
FALSE'
|
Antilipemic
|
06/20/2008
|
Kaletra
|
lopinavir/ ritonavir
|
Use in combination with other antiretroviral agents for HIV-1 infection
|
Extended indication from 6 months 12 years to 14 days 18 years The safety, efficacy, and pharmacokinetic profiles in pediatric patients < 14 days have not been established Dose should be calculated based on body weight or body surface area not to exceed adult dose Because no data exists for dosage when administered with efavirenz, nevirapine, (fos)amprenavir, or nelfinavir, it is recommended that lopinavir/ ritonavir not be administered in combination with these drugs in patients < 6 months of age Infants <6 months of age generally had lower lopinavir AUC12 than children 6 months 12 years of age Information on dose, PK parameters, clinical studies, and AEs
|
Labeling
|
|
|
B, P
|
|
Abbott
|
03/07/2008
|
FALSE'
|
Antiviral
|
06/20/2008
|
Pentacel
|
Diphtheria And Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine
|
Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Sanofi Pasteur
|
|
FALSE'
|
Preventive Vaccine
|
06/23/2008
|
Aptivus
|
tipranavir
|
Co-administered with ritonavir for combination antiretroviral in patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor
|
Extended indication from adults to children 2 years and older The risk-benefit has not been established in patients <2 years of age Dosing is based on body weight or body surface area not to exceed adult dose Aes are generally similar to those seen in adults however, rash was more frequent in pediatric patients than in adults; The frequency of rash through 48 weeks of treatment was 21%. Most rashes were mild and 5% were moderate. Overall 3% interrupted treatment due to rash Information on dose, Aes, PK parameters, lab abnormalities, and clinical study
|
Labeling
|
|
|
B, P
|
|
Boehringer Ingelheim
|
03/07/2008
|
FALSE'
|
Antiviral
|
06/24/2008
|
Viramune Tablets 200 mg Viramune Oral Suspension 10 mg/mL
|
nevirapine
|
Use in combination with other antiretroviral agents for the treatment of HIV-1 infection
|
Dosing information provided for children ages >15 days to <16 years old Safety was evaluated in children 2 weeks and older in 5 clinical trials and important adverse events (all causality) include rash (21%), neutropenia (8.9%), anemia (7.3%) and hepatotoxicity (2.4%) Safety, pharmacokinetics, and virologic and immunologic responses have been evaluated in HIV-infected pediatric patients age 3 months to 18 years Safety and pharmacokinetics were evaluated in HIV-infected pediatric patients age 15 days to < 3 months Efficacy was evaluated in one clinical study with children 3 months to 16 years of age Post-marketing surveillance has shown anemia to be more commonly observed in children although development of anemia due to concomitant medication use cannot be ruled out Potential drug interaction information is provided for children with respect to lopinavir/ritonavir New dosing regimen
|
Labeling
|
|
P
|
|
|
Boehringer Ingelheim
|
|
FALSE'
|
Antiviral
|
06/24/2008
|
KINRIX
|
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
|
Active immunization against diphtheria, tetanus, pertussis, & poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series when previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX and for the first three doses and INFANRIX for the fourth dose
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline Biologicals
|
|
FALSE'
|
Preventive Vaccine
|
06/30/2008
|
Aciphex
|
rabeprazole
|
Gastroesophageal reflux in adolescent patients 12 years of age and above
|
Use in adolescent patients 12 years of age and older is supported by extrapolation of results from studies in adults and safety and PK studies performed in adolescent patients Safety and effectiveness for GERD have not been established for pediatric patients <12 years of age Safety and effectiveness for other uses have not been established in pediatric patients Adverse events (Aes) similar to those seen in adults Information on dose, Aes, clinical studies
|
Labeling
|
|
|
B, P
|
|
Eisai Medical Research
|
|
FALSE'
|
Antiulcerative
|
07/01/2008
|
Flovent HFA
|
fluticasone propionate
|
Asthma in < 4 years
|
Flovent HFA should be administered by the orally inhaled route only in patients 4 years and older. Clinical studies were conducted in children with asthma 6 months to less than 4 years Information added to Pediatric Use
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Antiasthmatic
|
07/24/2008
|
Navstel Intraocular Irrigating Solution Sterile
|
balanced salt ophthalmic solution with hypromellose, dextrose and glutathione
|
Use as an intraocular irrigating solution during surgical procedures involving perfusion of the eye
|
Safety and efficacy have been demonstrated in pediatric patients New active ingredient
|
Labeling
|
|
P
|
|
|
Alcon
|
|
TRUE'
|
Ophthalmologic flush
|
07/29/2008
|
Cancidas
|
caspofungin
|
Empirical therapy for presumed fungal infections in febrile, neutropenic patients; Candidemia and certain Candida infections; Esophageal Candidiasis; Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies
|
Extended indication from adults to children 3 months and older based upon evidence from adequate and well-controlled studies in adults and PK data in pediatric patients and additional data from pediatric studies The efficacy and safety have not been adequately studied in infants < 3 months The ability of caspofungin to penetrate the blood-brain barrier and to treat patients with meningitis and endocarditis is unknown Dosing should be based on the patients body surface area. Maximum loading dose and daily maintenance dose should not exceed 70 mg The safety profile in pediatrics is comparably to adults Information on dose, Aes, PK parameters, clinical studies and infusion preparation instructions
|
Labeling
|
|
|
B, P
|
|
Merck
|
04/15/2008
|
FALSE'
|
Antifungal
|
08/14/2008
|
Zyprexa
|
olanzapine
|
schizophrenia; bipolar disorder
|
Safety and effectiveness have not been established for patients less than 18 years of age In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: oHyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo oHyperlipidemia statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol oWeight gain olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg
|
|
B
|
|
|
|
Lilly
|
01/10/2007
|
FALSE'
|
Antipsychotic
|
08/28/2008
|
Zemuron
|
rocuronium
|
Adjunct to general anesthesia
|
Expanded pediatric indication to include 0-17 years. Previously approved in ages 3 months 14 years Not recommended for rapid sequence intubation in pediatric patients In clinical studies of rocuronium, onset time and clinical duration varied with dose, the age of the patient, and anesthetic technique The overall analysis of ECG data in pediatric patients indicates that the concomitant use of rocuronium with general anesthetic agents can prolong the QTc interval The time to maximum block for an intubating dose was shortest in infants and longest in neonates. The duration of clinical relaxation following an intubating dose is shortest in children > 2 years to 11 years and longest in infants Additional information on dose, clinical studies, and PK/PD parameters
|
Labeling
|
|
|
B, P
|
|
Organon USA
|
04/03/2008
|
FALSE'
|
Anesthetic agent
|
09/03/2008
|
Valtrex
|
valacyclovir
|
Chickenpox; active or at risk for herpes virus infection
|
New indication for treatment of chickenpox in pediatric patients 2 to <18 years based on single-dose pharmacokinetic and multiple-dose safety data from an open-label trial with valacyclovir and supported by safety and extrapolated efficacy data from 3 randomized, double-blind, placebo-controlled trials evaluating oral acyclovir in pediatric patients with chickenpox The efficacy and safety of valacyclovir have not been established in pediatric patients: o <12 years of age with cold sores o<18 years of age with genital herpes o<18 years of age with herpes zoster o<2 years of age with chickenpox, ofor suppressive therapy following neonatal HSV infection Adverse events similar to that of adults Information on PK parameters, AEs, clinical studies, and preparation of an extemporaneous formulation
|
Labeling
|
|
|
B, P
|
|
GlaxoSmithKline
|
02/26/2008
|
FALSE'
|
Antiviral
|
09/12/2008
|
GARDASIL
|
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
|
Prevention of vulvar and vaginal cancer caused by HPV types 16 and 18
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Merck
|
|
FALSE'
|
Preventive Vaccine
|
09/19/2008
|
Retrovir syrup, capsules and tablets
|
zidovudine
|
Used in combination with 18 other antiretroviral agents for the treatment of HIV-1 infection
|
Dosing and administration information provided to children 6 weeks to less than 18 years of age Macrocytosis was reported in the majority of pediatric patients receiving Retrovir 180 mg/m2 every 6 hours in open-label studies New dosing regimen
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
TRUE'
|
Antiviral
|
09/19/2008
|
Nasacort AQ
|
triamcinolone
|
Treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older
|
Expands pediatric use, or age range, to include patients 2 to 5 years of age Dosing and administration information provided Not recommended for children under 2 years of age An effect on adrenal function in children 2 to 5 years of age cannot be ruled out Pharmacokinetics were evaluated in children 2 to 5 years of age Safety and efficacy were evaluated in one clinical study involving pediatric patients 2 to 5 years old Studies in children >6 months and less than 2 years of age were not performed due to safety concerns since controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients.
|
Labeling
|
|
P
|
|
|
Sanofi-Aventis
|
|
FALSE'
|
Anti-inflammatory, topical
|
09/29/2008
|
Videx EC
|
didanosine
|
HIV infection in >20 kg
|
Extended indication from adults to children weighing e20kg who can swallow capsules Dosing is based on body weight not to exceed adult dose Adverse events (AEs) are generally similar to those seen in adults Information on dose, AEs, population PK analysis, lab abnormalities, and historical clinical studies
|
Labeling
|
|
|
B, P
|
|
Bristol-Myers Squibb
|
08/13/2001
|
TRUE'
|
Antiviral
|
10/07/2008
|
Akten Ophthalmic gel 3.5%
|
lidocaine hydrochloride
|
Ocular surface anesthesia during ophthalmologic procedures
|
Safety and efficacy extrapolated from studies in adults and older pediatric patients using different ophthalmic formulations of lidocaine. New dosage form
|
Labeling
|
|
P
|
|
|
Akorn
|
|
TRUE'
|
Anesthetic, topical
|
10/08/2008
|
Zmax Oral Susp
|
azithromycin
|
Community-Acquired Pneumonia
|
Safety and effectiveness established in pediatric patients 6 months of age or older with community-acquired pneumonia. Use is supported by evidence from studies in adults with additional safety and PK data in pediatric patients Safety and effectiveness in the treatment of pediatric patients < 6 months of age have not been established. Safety and effectiveness in the treatment of pediatric patients with acute bacterial sinusitis have not been established Information on dose, PK parameters, AE profile, lab abnormalities, and clinical studies New indication
|
Labeling
|
|
P
|
|
|
Pfizer
|
|
TRUE'
|
Antibiotic
|
10/10/2008
|
Kogenate FS
|
Antihemophilic Factor (Recombinant)
|
Routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Bayer
|
|
FALSE'
|
Hematology/Coagulation
|
10/14/2008
|
Zomig Nasal Spray
|
zolmitriptan
|
Migraine
|
Safety and effectiveness have not been established in pediatric patients less than18 years of age. A single, multi-center, double-blind randomized placebo-controlled study failed to demonstrate efficacy in pediatric patients ages 12 -17 years for the acute treatment of migraine headaches Adverse events similar to those observed in adults.
|
|
|
|
B, P
|
|
AstraZeneca
|
12/18/2003
|
FALSE'
|
Antimigraine
|
10/21/2008
|
Acanya Gel
|
clindamycin/ benzoyl peroxide combination
|
Acne vulgaris in patients 12 years of age and older
|
Safety and effectiveness established in 2 clinical studies in patients 12 years of age and older Safety and effectiveness in pediatric patients under the age of 12 have not been evaluated New drug
|
Labeling
|
|
P
|
|
|
Dow
|
|
FALSE'
|
Antiacne, topical
|
10/24/2008
|
Apidra
|
insulin glulisine recombinant
|
Diabetes Mellitus
|
Extended indication from adults to pediatric patients 4 years and older with type 1 diabetes Has not been studied in pediatric patients less than 4 years with type 1 diabetes and in pediatric patients with type 2 diabetes Pediatric patients had a higher incidence of severe symptomatic hypoglycemia compared to adults in the clinical study New indication
|
Labeling
|
|
P
|
|
|
Sanofi-Aventis
|
|
FALSE'
|
Antidiabetic
|
10/28/2008
|
Prevacid
|
lansoprazole
|
Symptomatic GERD in infants
|
Effectiveness was not established in a 4 week multicenter, double-blind, placebo-controlled study of patients 1 month and < 12 months of age AE profile similar to that observed in adultsInformation on PK parameters in neonates to < 1 year, and clinical studies
|
Labeling
|
|
|
B, P
|
|
Takeda
|
07/15/2008
|
FALSE'
|
Antiulcerative
|
11/14/2008
|
Neulasta
|
Pefilgrastim
|
Decrease the incidence of infection in pediatric patients with sarcoma
|
Safety and effectiveness in pediatric patients have not been established Safety and PK were studied in 37 pediatric patients with sarcoma Information added to Pediatric Use
|
Labeling
|
|
P
|
|
|
Amgen
|
|
FALSE'
|
Hematopoietic
|
12/05/2008
|
Arimidex
|
anastrozole
|
Male pubertal patients with gynecomastia and female pediatric patients with McCune-Albright syndrome with progressive precocious puberty
|
Efficacy has not been demonstrated in clinical studies of anastrozole in the treatment of pubertal gynecomastia in adolescent boys 11-18 years and in the treatment of precocious puberty in girls with McCune-Albright Syndrome 2 to < 10 years Information on clinical studies, AEs, and PK parameters
|
Labeling
|
B
|
|
|
|
AstraZeneca
|
11/14/2007
|
FALSE'
|
Estrogen lowering agent
|
12/11/2008
|
PegIntron
|
Peginterferon alfa-2b
|
Co-administered with ritonavir to treat chronic hepatitis C in patients 3 years of age and older with compensated liver disease previously untreated with interferon alpha
|
Safety and efficacy established in pediatric patients 317 years of age Safety and effectiveness in patients < 3 years have not been established. Dosing for pediatric patients is determined by body surface area for peginterferon alfa-2b and by body weight for ritonavir An open-label study in patients 3 - 17 years showed weight and height gain of pediatric patients treated with combination therapy lags behind that predicted by population data while on treatment. Adverse events similar to those observed in adults. Most common pediatric adverse events were pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema, vomiting Information on PK parameters, and clinical study New indication
|
Labeling
|
|
P
|
|
|
Schering
|
|
FALSE'
|
Antiviral
|
12/17/2008
|
Epiduo
|
adapalene and benzoyl peroxide
|
Topical treatment of acne vulgaris in patients 12 years of age and older
|
Safety and effectiveness established in patients 12 years of age and older Safety and effectiveness in pediatric patients under the age of 12 have not been established New drug
|
Labeling
|
|
P
|
|
|
Galderma
|
|
FALSE'
|
Antiacne, topical
|
12/18/2008
|
Prezista
|
darunavir
|
Treatment of HIV infection in pediatric patients 6 years and older when co-administered with ritonavir (Prezista/rtv), and with other antiretroviral agents
|
Extended indication from adults to pediatric patients 6 years and older Safety and effectiveness in pediatric patients 3 to < 6 years of age have not been established Do not administer in pediatric patients below 3 years of age Do not administer Prezista/rtv once daily in pediatric patients Dosing for patients 6 to < 18 years and weighing at least 44 lbs (20 kg) is based on body weight not to exceed adult dose AE similar to those seen in adults Information on dose, Aes, PK parameters, lab abnormalities, and clinical study
|
Labeling
|
|
|
B, P
|
|
Tibotec
|
06/07/2011
|
FALSE'
|
Antiviral
|
12/19/2008
|
Ziagen
|
abacavir
|
HIV infection
|
Provided new scored tablet for use in pediatric patients weighing >14 kg who can swallow tablets New dosing regimen
|
Labeling
|
|
|
B, P
|
|
GlaxoSmithKline
|
12/14/1998
|
TRUE'
|
Antiviral
|
12/19/2008
|
Casodex
|
bicalutamide
|
Gonadotropin-independent precocious puberty in boys with familial male-limited precocious puberty (testotoxicosis)
|
Safety and effectiveness have not been established in pediatric patients Bicalutamide was studied in combination with anastrozole in an open-label, non-comparative, multi-center study that assessed the efficacy and safety of this combination regimen over 12 months in the treatment of testotoxicosis in patients e2 years Of the 14 patients exposed to study treatment, 13 had at least one adverse event. Adverse reactions considered possibly related to bicalutamide included gynecomastia (43%), central precocious puberty (14%), breast tenderness (14%), breast pain (7%), asthenia (7%), increased alanine aminotransferase (7%), increased aspartate aminotransferase (7%), and musculoskeletal chest pain (7%). Headache was the only adverse reaction considered possibly related to anastrozole Information on clinical studies, AEs, and PK parameters
|
Labeling
|
B
|
|
|
|
AstraZeneca
|
09/19/2008
|
FALSE'
|
Androgen blocker
|
03/19/2009
|
Lexapro
|
escitalopram oxalate
|
Major depressive disorder in adolescents
|
Safety and effectiveness have been established in adolescents 12 to 17 years for the treatment of MDD. Maintenance efficacy is supported from extrapolation of data from adult studies along with comparisons with racemic citalopram pharmacokinetic parameters in adults and adolescents. Safety and effectiveness have not been established in pediatric patients <12 years with MDD Safety and effectiveness have not been established in pediatric patients less than 18 years of age with Generalized Anxiety Disorder Adverse events generally similar to those observed in adults Information on dosing, adverse events, PK parameters, and clinical studies Patient population altered
|
Labeling
|
B
|
|
|
|
Forest Laboratories
|
07/12/2002
|
FALSE'
|
Antidepressant
|
04/09/2009
|
Ulesfia Lotion, 5%
|
benzyl alcohol
|
Treatment of head lice
|
Safety and effectiveness established in pediatric patients 6 months and older Safety in pediatric patients < 6 months has not been established. Not recommended in pediatric patients < 6 months due to potential for increased systemic absorption Neonates are at risk of gasping syndrome due to benzyl alcohol Adverse events similar to those observed in adults Information on dosing and administration, warnings and precautions, adverse events, PK parameters, and clinical studies New drug
|
Labeling
|
|
P
|
|
|
Sciele Pharma Inc
|
|
FALSE'
|
Pediculocide, topical
|
04/14/2009
|
Suprane
|
desflurane
|
Safety study of 2 agents used for maintenance of anesthesia in non-intubated patients
|
Postmarketing Reports subsection added to the Adverse Events section of labeling, including reports of cardiac disorders. Postmarketing reports are voluntary; it is not possible to estimate frequency or causality to drug exposure.
|
Labeling
|
B
|
|
|
|
Baxter
|
09/13/2006
|
TRUE'
|
Anesthetic agent
|
04/30/2009
|
Axert
|
almotriptan
|
Acute treatment of pediatric migraine in adolescent patients age 12-17 years
|
Safety and effectiveness established in patients 12 17 years. Efficacy on migraine associated symptoms (nausea, photophobia and phonophobia) was not established. Safety and effectiveness in pediatric patients < 12 years have not been established The most common adverse events were dizziness, somnolence, headache, paresthesia, nausea and vomiting. Safety and tolerability similar to adults. Information on dosing, adverse events, PK parameters, clinical study Patient population altered
|
Labeling
|
B
|
|
|
|
Ortho-McNeil
|
01/13/2009
|
FALSE'
|
Antimigraine
|
04/30/2009
|
Creon
|
pancrelipase
|
Exocrine pancreatic insufficiency due to cystic fibrosis or other conditions
|
Safety and efficacy assessed in a study that included patients 12-18 years Safety and efficacy for use in all pediatric age groups based on information from the literature and clinical experience with different formulations of pancrelipase containing the same active ingredient. High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age AEs similar to adults Capsule should be swallowed whole. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce Information on dosing and clinical study Not interchangeable with other pancrelipase products New drug
|
Labeling
|
|
P
|
|
|
Solvey
|
|
FALSE'
|
Pancreatic enzyme
|
05/01/2009
|
Cetraxal
|
ciprofloxacin otic solution
|
Treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus
|
Efficacy in pediatric patients 1 year and older has been demonstrated in controlled clinical trials Safety and effectiveness in infants < 1 year have not been established There is no evidence that the otic administration of quinolones has any effect on weight bearing joints Information on AE profile and clinical study New dosage form
|
Labeling
|
|
P
|
|
|
Salvat
|
|
FALSE'
|
Antibiotic, topical
|
05/08/2009
|
Lamictal
|
lamotrigine
|
Adjunctive treatment for partial seizures in pediatric patients 1 24 months
|
Safety and effectiveness as adjunctive treatment for partial seizures were not demonstrated in a small randomized, double-blind, placebo-controlled, withdrawal study in pediatric patients 1 - 24 months Immediate release tablets were associated with an increased risk for infectious adverse reactions including bronchiolitis, bronchitis, ear infection, eye infection, otitis externa, pharyngitis, urinary tract infection, and viral infection (Lamictal 37%, Placebo 5%), and respiratory adverse reactions including nasal congestion, cough, and apnea. (Lamictal 26%, Placebo 5%)
|
Labeling
|
B
|
|
|
|
GlaxoSmithKline
|
02/14/2007
|
FALSE'
|
Anticonvulsant
|
05/28/2009
|
Besivance
|
besifloxacin ophthalmic suspension
|
Treatment of bacterial conjunctivitis
|
Efficacy in pediatric patients 1 year and older has been demonstrated in controlled clinical trials Safety and effectiveness in infants < 1 year of age have not been established There is no evidence that the ophthalmic administration of quinolones has any effect on weight bearing joints Information on AE profile and clinical study New drug
|
Labeling
|
|
P
|
|
|
Bausch and Lomb
|
|
FALSE'
|
Antibiotic, topical
|
05/29/2009
|
Lamictal XR
|
lamotrigine
|
Adjunctive therapy for partial onset seizures in patients e13 years of age
|
Extended release tablets are indicated as adjunctive therapy for partial onset seizures with or without secondary generalization in patients e13 years Safety and effectiveness of extended release tablets for any use in patients below the age of 13 have not been established Information on adverse event profile, and clinical studies New dosage form
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Anticonvulsant
|
06/18/2009
|
Nexium
|
esomeprazole
|
Short-term treatment of GERD
|
Effectiveness was not demonstrated in a randomized, placebo-controlled study in neonates to < 1 year Information on clinical study, PK/PD parameters
|
Labeling
|
|
|
B, P
|
|
AstraZeneca
|
05/01/2009
|
FALSE'
|
Antiulcerative
|
07/10/2009
|
Plan B One Step
|
levonorgestrel
|
Emergency contraception - OTC in women 17 years and older; RX for women younger than age 17 years
|
New single dose 1.5 mg tablet New dosage regimen
|
Labeling
|
|
P
|
|
|
Duramed
|
|
FALSE'
|
Contaceptive
|
07/23/2009
|
Actonel
|
risedronate
|
Osteogenesis imperfecta
|
Safety and effectiveness have not been established in pediatric patients In a 1 year double-blind, placebo controlled study of pediatric patients with osteogenesis imperfecta (OI), treatment with risedronate did not result in a reduction in the risk of fracture Adverse events similar to those observed in adults except for an increased incidence in vomiting Information on clinical study
|
Labeling
|
B
|
|
|
|
Procter & Gamble
|
04/24/2009
|
FALSE'
|
Bone density
|
07/31/2009
|
Xerese
|
acyclovir/ hydrocortisone
|
Recurrent herpes labialis (cold sores) in 12 years of age and older
|
Use in adolescents e12 years is supported by evidence from studies in adults with additional safety data in adolescents e12 years Safety and effectiveness in pediatric patients < 12 years have not been established Information on clinical studies, and adverse events New drug
|
Labeling
|
|
P
|
|
|
Medivir
|
|
FALSE'
|
Antiviral, topical
|
08/19/2009
|
HIBERIX
|
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
|
Active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Preventive Vaccine
|
08/21/2009
|
Xyzal
|
levocetirizine dihydrochloride
|
Seasonal allergic rhinitis (SAR) in children 2 years of age and older; perennial allergic rhinitis (PAR) and chronic idiopathic urticaria (CIU) for children 6 months of age and older
|
Expanded age range for CIU down to 6 months; previously approved for use in 12 years and older Expanded age range for PAR down to 6 months; previously approved for use in 6 years and older Expanded age range for SAR down to 2 years; previously approved for use in 6 years and older Pediatric use is supported by evidence from studies in adults with additional safety and PK data in pediatrics Patient population altered
|
Labeling
|
|
|
B, P
|
|
UCB
|
08/25/2009
|
FALSE'
|
Antihistamine
|
08/27/2009
|
Zenpep
|
pancrelipase
|
Exocrine pancreatic insufficiency due to cystic fibrosis
|
Safety and efficacy assessed in 2 studies which included pediatric patients ages 1-17 years Safety and efficacy for use in all pediatric age groups based on information from the literature and clinical experience with different formulations of pancrelipase with the same active ingredient. High doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures in children <12 years of age AEs similar to adults Capsule should be swallowed whole. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce Information on dosing, and clinical studies Not interchangeable with other pancrelipase products New drug
|
Labeling
|
|
P
|
|
|
Eurand
|
|
FALSE'
|
Pancreatic enzyme
|
08/28/2009
|
Valcyte
|
valganciclovir
|
Prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients e 4 months of age
|
Use in pediatric patients e 4 months is based on efficacy data from a study in adults and PK, safety, and efficacy data from an open-label trial in pediatric solid organ transplant recipients at risk for developing CMV disease The efficacy and safety have not been established in children for: 1.Prevention of CMV disease in liver transplant patients 2.Prevention of CMV disease in solid organ transplants other than those indicated 3.Prevention of CMV disease in pediatric solid organ transplant patients < 4 months of age 4.Treatment of congenital CMV disease Adverse events (AEs) similar to adult patients, however, certain Aes including upper respiratory tract infection, pyrexia, nasopharyngitis, anemia, and neutropenia were reported more frequently in pediatric patients Information on dosing, PK, and clinical study New dosage form
|
Labeling
|
|
|
B, P
|
|
Roche
|
07/24/2008
|
FALSE'
|
Antiviral
|
08/31/2009
|
Astepro Nasal Spray
|
azelastine hydrochloride
|
Seasonal and perennial allergic rhinitis in patients 12 years of age and older.
|
Safety and efficacy for the treatment of seasonal and perennial allergic rhinitis were evaluated in 7 controlled clinical trials in patients 12 years and older Information on clinical trials, dosing, and adverse events (AEs) New indication (PAR) and dosing regimen
|
Labeling
|
|
P
|
|
|
Meda
|
|
FALSE'
|
Antihistamine
|
09/02/2009
|
Intuniv
|
guanfacine
|
ADHD
|
Efficacy established in 2 controlled clinical trials in children 6-17 years Safety and efficacy in pediatric patients< 6 years have not been established In clinical trials, there were dose and exposure-related risks for adverse events (AEs) including hypotension, bradycardia, and sedative events. Somnolence and sedation were reported in 38% on guanfacine vs. 12% on placebo in children and adolescents with ADHD, especially during initial use Information on dosing, clinical trials, and AEs New dosage form
|
Labeling
|
|
P
|
|
|
Shire
|
|
FALSE'
|
Non-stimulant ADHD treatment
|
09/08/2009
|
Bepreve Ophthalmic Solution
|
bepotastine besilate
|
Ocular itching associated with allergic conjunctivitis
|
Efficacy in pediatric patients 2 years to < 10 years based on clinical trials conducted in pediatric patients > 10 years and from adults Safety and efficacy have not been established in pediatric patients < 2 years New drug
|
Labeling
|
|
P
|
|
|
Ista Pharmaceuticals
|
|
FALSE'
|
Antihistamine, topical
|
09/18/2009
|
AndroGel
|
testosterone
|
Use in adolescent boys with delayed puberty
|
New safety information added to labeling including a Boxed Warning, and revisions to the Warnings and Precautions, Adverse Reactions, and Patient Counseling sections on the risk of virilization from secondary exposure of children to testosterone due to drug transfer from unwashed or uncovered application skin sites of adult males using testosterone gel products Safety and efficacy have not been established in males < 18 years
|
Labeling
|
B
|
|
|
|
Unimed
|
08/22/2007
|
TRUE'
|
Androgen-anabolic steroid
|
10/01/2009
|
Mirena
|
levonorgestrel-releasing intrauterine system
|
Treatment of heavy menstrual bleeding for women using intrauterine contraception
|
New indication for the treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception Use before menarche is not indicated
|
Labeling
|
|
P
|
|
|
Berlex
|
|
TRUE'
|
Contaceptive
|
10/02/2009
|
Welchol
|
colesevelam
|
Heterozygous familial hypercholesterolemia
|
New indication for use as monotherapy or with a statin in boys and postmenarchal girls 10-17 years with heterozygous familial hypercholesterolemia Has not been studied in children < 10 years or in pre-menarchal girls Information on dose, adverse events and clinical studies
|
Labeling
|
|
|
B, P
|
|
Daiichi Sankyo
|
02/17/2009
|
FALSE'
|
Antilipemic
|
10/15/2009
|
Crestor
|
rosuvastatin
|
Heterozygous familial hypercholesterolemia
|
New indication in adolescent boys and girls (at least one year post-menarche) 10-17 years with heterozygous familial hypercholesterolemia Has not been studied in children < 10 years or in pre-menarchal girls Information on dose, adverse events and clinical studies
|
Labeling
|
|
|
B, P
|
|
AstraZeneca
|
07/07/2009
|
FALSE'
|
Antilipemic
|
10/16/2009
|
CERVARIX
|
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
|
Prevention of genital warts caused by HPV 16 and 18
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Merck
|
|
FALSE'
|
Preventive Vaccine
|
10/16/2009
|
GARDASIL
|
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
|
Prevention of genital warts caused by HPV 6 and 11
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Merck
|
|
FALSE'
|
Preventive Vaccine
|
10/19/2009
|
Fluarix
|
Influenza Virus Vaccine
|
Active immunization for the prevention of influenza disease caused by virus types A and B contained in the vaccine
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Preventive Vaccine
|
10/22/2009
|
Atacand
|
candesartan
|
Hypertension
|
Expanded indication from adults to pediatric patients 1 to < 17 years of age. Children < 1 year must not receive candesartan. Administering drugs that act directly on the renin-angiotensin system can have effects on the development of immature kidneys Children with glomerular filtration rate < 30ml/min/1.73m2 should not receive candesartan. In clinical trials, 4 of 233 children experienced worsening renal disease Information on preparation of an oral suspension, dosing and administration, adverse events, pharmacokinetics, and clinical trials
|
Labeling
|
B
|
|
|
|
AstraZeneca
|
07/20/2009
|
FALSE'
|
Antihypertensive
|
10/23/2009
|
Focalin XR
|
dexmethylphenidate
|
ADHD
|
Revised maximum daily dosing due to dose-response studies. Doses above 30 mg/day in pediatrics and 40 mg/day in adults have not been studied and are not recommended Dosing should be individualized to patient needs and response. There was no clear benefit of the higher doses compared to the lower doses. Adverse events and discontinuations were dose-related. New dosing regimen; new dosage strength (30 mg capsule)
|
Labeling
|
|
P
|
|
|
Novartis
|
|
FALSE'
|
CNS Stimulant
|
11/06/2009
|
Retrovir
|
zidovudine
|
Treatment of HIV-1 infection in combination with other antiretroviral agents
|
Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
TRUE'
|
Antiviral
|
11/10/2009
|
AFLURIA
|
Influenza Virus Vaccine
|
Active immunization for the prevention of influenza disease caused by virus types A and B contained in the vaccine
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
CSL Limited
|
|
FALSE'
|
Preventive Vaccine
|
11/12/2009
|
Protonix
|
pantoprazole
|
GERD
|
Extended indication from adults to pediatric patients 5 years of age and older Use in pediatric patients 1 to 16 years of age is supported by extrapolation from studies in adults, and safety, efficacy and PK studies performed in pediatric patients There is no age-appropriate formulation available for patients less than 5 years of age Effectiveness was not demonstrated in a clinical trial of patients 1 month to 11 months of age with symptomatic GERD Safety and effectiveness for pediatric uses other than EE have not been established Information on adverse reactions, pharmacokinetics, and clinical studies
|
Labeling
|
|
|
B, P
|
|
Wyeth
|
02/17/2009
|
FALSE'
|
Antiulcerative
|
11/19/2009
|
Abilify
|
aripiprazole
|
Irritability associated with autistic disorder
|
Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two placebo-controlled clinical trials in pediatric patients 6 - 17 years of age Most common adverse reactions observed in pediatric clinical trials in patients with autistic disorder included sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy. Fatigue was a possible dose-response adverse reaction. Information on dosing, adverse reactions, and clinical studies
|
Labeling
|
|
P
|
|
|
Otsuka
|
|
FALSE'
|
Antipsychotic
|
12/01/2009
|
Patanase
|
olopatadine
|
Seasonal allergic rhinitis
|
Expanded age range down to 6 years; previously approved for use in 12 years and older Safety and effectiveness have not been established in < 6 years of age The incidence of epistaxis (nosebleed) was higher in children 6 -11 years of age compared to the adult and adolescent population Information on clinical trials, adverse reactions, and new one spray per nostril twice daily dosing in 6-11 years
|
Labeling
|
|
|
B, P
|
|
Alcon
|
08/12/2009
|
FALSE'
|
Antihistamine
|
12/02/2009
|
Seroquel
|
quetiapine
|
Treatment of schizophrenia in adolescents 13 to 17 years of age and the treatment of bipolar mania in children and adolescents 10 to 17 years of age
|
Extended schizophrenia indication from adults to adolescents 1317 years of age; extended bipolar mania indication from adults to children and adolescents 10-17 years of age Safety and effectiveness in children < 13 years of age with schizophrenia have not been established; safety and effectiveness in children < 10 years of age with bipolar mania have not been established Most adverse reactions in pediatric clinical trials were similar to those observed in adults and included somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, and weight increase. However, increases in blood pressure and potentially clinically significant increases in heart rate (> 110 bpm) occurred in children and adolescents and did not occur in adults. Information on dosing, adverse reactions, pharmacokinetics, and clinical studies
|
Labeling
|
|
|
B, P
|
|
AstraZeneca
|
01/23/2009
|
FALSE'
|
Antipsychotic
|
12/04/2009
|
Zyprexa
|
olanzapine
|
Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17
|
Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age Safety and effectiveness in children < 13 years of age have not been established Recommended starting dose for adolescents is lower than that for adults Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels Information on dosing, adverse reactions, pharmacokinetics, clinical studies
|
Labeling
|
B
|
|
|
|
Lilly
|
01/10/2007
|
TRUE'
|
Antipsychotic
|
12/14/2009
|
Daytrana
|
methylphenidate
|
Postmarketing safety study
|
Information added to Warnings and Adverse Reactions on skin reactions observed in a postmarketing dermal study in pediatric patients
|
Labeling
|
|
P
|
|
|
Shire
|
|
FALSE'
|
CNS Stimulant
|
12/22/2009
|
Flomax
|
tamsulosin
|
Treatment of elevated detrusor leak point pressure associated with neurological disorder
|
Efficacy and positive benefit/risk was not demonstrated in 2 studies (a randomized, double-blind, safety and efficacy study and an open label safety study) conducted in patients 2 -16 years The most frequently reported adverse events from the 2 studies were urinary tract infection, vomiting, pyrexia, headache, nasopharyngitis, cough, pharyngitis, influenza, diarrhea, abdominal pain, and constipation. Information added to Pediatric Use
|
Labeling
|
B
|
|
|
|
Boehringer Ingelheim
|
09/17/2009
|
FALSE'
|
Urology
|
12/22/2009
|
Topamax
|
topiramate
|
Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 months
|
Effectiveness was not demonstrated as adjunctive therapy in a randomized, double-blind trial in infants/toddlers 1 to 24 months of age with refractory partial onset seizures Trials in infants/toddlers 1 to 24 months suggested some adverse reactions/toxicities not previously observed in older pediatric patients and adults; i.e, growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications. Information added to Warnings and Precautions and Pediatric Use
|
Labeling
|
B
|
|
|
|
Ortho-McNeil-Janssen
|
07/24/2008
|
FALSE'
|
Anticonvulsant
|
12/22/2009
|
Topamax
|
topiramate
|
Migraine Prophylaxis
|
Safety and effectiveness for migraine prevention in pediatric patients have not been established Dose-related increased shift in serum creatinine in adolescent patients occurred in a clinical study Information added to Warnings and Precautions and Pediatric Use
|
Labeling
|
|
P
|
|
|
Ortho-McNeil-Janssen
|
|
FALSE'
|
Anticonvulsant
|
12/24/2009
|
Famvir
|
famciclovir
|
Treatment of children 1 month 12 years of age w/ herpes simplex (HSV) & 1 12 years w/ varicella zoster (VSV)
|
Available data are insufficient to support the use of famciclovir for the treatment of children with chickenpox or infections due to HSV The PK profile and safety were studied in 2 open-label studies: (1) a single-dose PK and safety study in infants 1 month to <1 year of age who had an active herpes simplex virus (HSV) infection or who were at risk for HSV infection and (2) a single-dose PK, multiple-dose safety study in children 1 to <12 years of age with clinically suspected HSV or varicella zoster virus (VZV) infection Information added to Pediatric Use
|
Labeling
|
|
|
B, P
|
|
Novartis
|
09/21/2009
|
FALSE'
|
Antiviral
|
01/04/2010
|
Xolair
|
omalizumab
|
Moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.
|
Safety and effectiveness were evaluated in 2 studies in 926 asthma patients 6 to <12 years of age. The risk-benefit assessment does not support use in patients 6 to <12 years considering the risk of anaphylaxis and malignancy seen in Xolair-treated patients e12 years and the modest efficacy of Xolair in the pivotal pediatric study Studies in patients 0-5 years were not required due to safety concerns of anaphylaxis and malignancy Information added to Pediatric Use
|
Labeling
|
|
P
|
|
|
Genentech
|
|
FALSE'
|
Antiasthmatic
|
01/25/2010
|
Sandostatin and Sandostatin LAR
|
octreotide
|
Weight loss due to hypothalamic obesity from cranial insult
|
Post-marketing reports of hypoxia, necrotizing enterocolitis, and death in children added to Pediatric Use. The relationship of these events to octreotide has not been established. Pediatric Use subsection of Sandostatin labeling harmonized with Sandostatin LAR labeling
|
Labeling
|
B
|
|
|
|
Novartis
|
01/12/2006
|
TRUE'
|
Endocrine agent
|
01/29/2010
|
Lamictal XR
|
lamotrigine
|
Adjunctive therapy for Primary Generalized Tonic-Clonic seizures
|
New indication for adjunctive therapy for primary generalized tonic-clonic seizures in patients e 13 years of age Safety and effectiveness for any use in patients < 13 years have not been established Information on dosing, adverse reactions, and clinical studies
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Anticonvulsant
|
02/04/2010
|
Benicar
|
olmesartan
|
Hypertension
|
Expanded indication from adults to pediatric patients 6 years and older Information on preparation of an oral suspension Adverse events similar to adult patients Information on dosing, adverse reactions, pharmacokinetics, and clinical studies
|
Labeling
|
|
|
B, P
|
|
Daiichi Sankyo
|
10/07/2009
|
FALSE'
|
Antihypertensive
|
02/19/2010
|
MENVEO
|
Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
|
Active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Novartis
|
|
FALSE'
|
Preventive Vaccine
|
02/22/2010
|
TamiFlu
|
oseltamivir
|
Prophylaxis of influenza
|
Information on postmarketing clinical study in patients 1 to 12 years
|
Labeling
|
|
P
|
|
|
Hoffmann-La Roche Inc.
|
|
FALSE'
|
Antiviral
|
02/24/2010
|
Prevnar 13
|
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
|
Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Wyeth
|
|
FALSE'
|
Preventive Vaccine
|
03/17/2010
|
Differin Lotion
|
adapalene
|
Acne
|
Safety and effectiveness established in 2 clinical studies in patients 12 years and older Safety and effectiveness in pediatric patients less than 12 years have not been established New dosage form
|
Labeling
|
|
P
|
|
|
Galderma
|
|
FALSE'
|
Antiacne, topical
|
03/17/2010
|
MultiHance Injection
|
gadobenate dimeglumine
|
Intravenous use in magnetic resonance imaging
|
Extended indication from adults to pediatric patients 2 years and older Safety and effectiveness in pediatric patients less than 2 years have not been established Patients less than 2 years may be at increased risk of nephrogenic systemic fibrosis related to gadolinium due to immature kidney function Adverse events similar to adult patients Information on adverse events, PK, and clinical studies New indication
|
Labeling
|
|
P
|
|
|
Bracco Diagnostics
|
|
FALSE'
|
Diagnostic aid
|
03/24/2010
|
Viread
|
tenofovir disoproxil fumarate
|
Treatment of HIV infection in combination with other antiretroviral agents
|
Expanded indication from adults to pediatric patients 12- <18 years Safety and effectiveness in patients < 12 years have not been established In a clinical study of HIV-1 infected adolescents bone effects were similar to adults The adverse reactions in trial in adolescents were consistent with those observed in clinical trials in adults Information on dosing in adolescents weighing e35 kg, adverse reactions, and PK parameters
|
Labeling
|
|
|
B, P
|
|
Gilead
|
|
FALSE'
|
Antiviral
|
04/12/2010
|
Pancreaze
|
pancrelipase
|
Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions
|
Safety and efficacy assessed in 2 studies that included patients 6-30 months and 8--17 years Safety and efficacy for use in all pediatric age groups based on information from the literature and clinical experience with different formulations of pancrelipase containing the same active ingredient High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age Adverse reactions similar to adults Capsule should be swallowed whole. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce Information on dosing and clinical studies Not interchangeable with other pancrelipase products New drug
|
Labeling
|
|
P
|
|
|
Ortho-McNeil-Janssen
|
|
FALSE'
|
Pancreatic enzyme
|
05/06/2010
|
Natazia
|
estradiol valerate and estradiol valerate/dienogest
|
Prevention of pregnancy
|
Safety and efficacy have been established in women of reproductive age. Safety and efficacy for post pubertal adolescents < 18 are expected to be the same as for 18 years and older Use of this product before menarche is not indicated New drug
|
Labeling
|
|
P
|
|
|
Bayer
|
|
TRUE'
|
Contaceptive
|
05/07/2010
|
Omnaris Nasal Spray
|
ciclesonide
|
Postmarketing study
|
Information on clinical study to assess effect of orally inhaled ciclesonide on growth
|
Labeling
|
|
P
|
|
|
Sepracor
|
|
TRUE'
|
Antiasthmatic; antiallergy
|
05/13/2010
|
Taxotere
|
docetaxel
|
Solid Tumors
|
Efficacy in pediatric patients as monotherapy or in combination has not been established. Taxotere has been studied in a total of 289 pediatric patients: 239 in 2 trials with monotherapy and 50 in combination treatment with cisplatin and 5-fluoruracil The overall safety profile in pediatric patients receiving monotherapy or combination treatment was consistent with the safety profile in adults Information on dosing, clinical trials and PK parameters
|
Labeling
|
B
|
|
|
|
Sanofi-Aventis
|
03/17/2010
|
FALSE'
|
Antineoplastic
|
05/18/2010
|
Zymaxid
|
gatifloxacin
|
Bacterial conjunctivitis
|
Safety and effectiveness have been demonstrated in clinical trials for the treatment of bacterial conjunctivitis in pediatric patients 1 year and older The safety and effectiveness in infants < 1year have not been established Information on adverse reactions and clinical trials New drug
|
Labeling
|
|
P
|
|
|
Allergan
|
|
FALSE'
|
Antibiotic
|
05/26/2010
|
Nasonex
|
mometasone
|
Nasal congestion associated with seasonal allergic rhinitis
|
New indication in pediatric patients 2 years and older Safety and effectiveness evaluated in 3 clinical studies in 12 years and older. Use in pediatric patients 2 - 11 years is supported by data from other pediatric clinical studies Safety and effectiveness for any use in patients < 2 years have not been established Information on dosing, adverse reactions, and clinical studies in 12 years and older New indication
|
Labeling
|
|
|
|
|
Schering-Plough
|
|
FALSE'
|
Anti-inflammatory, topical
|
06/03/2010
|
Zylet
|
loteprednol etabonate and tobramycin
|
Eye lid inflammation
|
Efficacy was not demonstrated in a study of pediatric patients 0-6 years
|
Labeling
|
|
|
B,
|
40540
|
Bausch and Lomb
|
12/28/2010
|
FALSE'
|
Anti-inflammatory, Antibiotic
|
06/22/2010
|
Isopto Carpine
|
pilocarpine hydrochloride
|
Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension; management of acute angle closure glaucoma; prevention of postoperative elevated IOP associated with laser surgery and induction of miosis
|
Safety and effectiveness in pediatric patients have been established Not recommended in pediatric patients diagnosed with glaucoma due to anterior segment dysgenesis or uveitis Caution is advised in pediatric patients with primary congenital glaucoma for control of IOP as cases of a paradoxical increase in IOP have been reported. Adverse events similar to adults New dosage form
|
Labeling
|
|
P
|
|
|
Alcon
|
|
TRUE'
|
Ophthalmologic hypotensive
|
06/22/2010
|
Dulera Inhalation Aerosol
|
mometasone furoate and formoterol fumarate
|
Asthma
|
Safety and effectiveness have been established in patients 12 years and older in 3 clinical studies Safety and efficacy have not been established in children <12 years Data from clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients Information on adverse events and clinical studies New combination
|
Labeling
|
|
P
|
|
|
Schering
|
|
FALSE'
|
Antiasthmatic
|
06/25/2010
|
Serevent
|
salmeterol
|
Asthma
|
Available data from controlled clinical trials suggest that Long Acting Beta Agonists (LABAs) increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g. inhaled corticosteroid) and LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components.
|
Labeling
|
B
|
|
|
|
GlaxoSmithKline
|
03/09/2006
|
TRUE'
|
Antiasthmatic
|
06/29/2010
|
Daytrana
|
methylphenidate
|
ADHD
|
Expanded pediatric indication to include adolescent patients ages13-17 years The most commonly reported adverse reactions in a trial in patients 13-17 years included appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia. The majority of patients had erythema at the application site Information on PK parameters, Adverse Event profile and clinical studies
|
Labeling
|
|
P
|
|
|
Shire
|
|
FALSE'
|
CNS Stimulant
|
07/28/2010
|
Lastacaft Ophthalmic Solution
|
alcaftadine
|
Prevention of itching associated with allergic conjunctivitis.
|
Safety and effectiveness in patiente 2 years were established in controlled clinical trials Safety and effectiveness in pediatric patients< 2 years have not been established New drug
|
Labeling
|
|
P
|
|
|
Vistakon Pharmaceuticals,
|
|
FALSE'
|
Antihistamine, topical
|
08/13/2010
|
ella
|
ulipristal acetate
|
Prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure
|
Safety and efficacy have been established in women of reproductive age. Safety and efficacy are expected to be the same for post pubertal adolescents <18 years and for users 18 years and older. Use of ella before menarche is not indicated New drug
|
Labeling
|
|
P
|
|
|
Laboratoire HRA Pharma
|
|
TRUE'
|
Contraceptive
|
08/27/2010
|
Augmentin XR
|
amoxicillin/clavulanate potassium
|
Community-acquired pneumonia or acute bacterial sinusitis
|
Expanded indication from adults to children weighing e 40 kg who are able to swallow tablets Use in children is supported by evidence from trials of adults with additional data from a pediatric PK study Adverse events similar to adults Information on dose, and PK parameters Information added to Clinical Pharmacology and Pediatric Use
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Antibiotic
|
09/24/2010
|
Beyaz
|
drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium
|
Prevention of pregnancy; premenstrual dysphoric disorder; moderate acne vulgaris e14 years who have achieved menarche; to raise folate levels in a pregnancy conceived while on or shortly after discontinuing the product
|
Safety and efficacy have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents <18 years and for users e18 years Use before menarche is not indicated New combination
|
Labeling
|
|
P
|
|
|
Bayer
|
|
TRUE'
|
Contraceptive
|
09/28/2010
|
Kapvay Extended Release Tablets
|
clonidine
|
Treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications
|
New indication in children 6 years and olderEfficacy is based on 2 clinical trials in children and adolescents 6 -17 years Kapvay has not been studied in children with ADHD < 6 yearsKapvay can cause dose related decreases in blood pressure and heart rateCommon adverse events reported in clinical trials included somnolence, fatigue, upper respiratory tract infection irritability, throat pain, insomnia, nightmares, emotional disorder. In fixed dose pediatric monotherapy study, 31% of patients treated with 0.4 mg/day and 38% treated with 0.2 mg/day vs 7% of placebo treated patients reported somnolence. Kapvay is an extended-release tablet formulation of clonidine; therefore, it is not to be used interchangeably with the immediate-release formulationInformation on adverse events, and clinical trialsNew indication
|
Labeling
|
|
P
|
|
|
Shionogi
|
|
FALSE'
|
Non-stimulant ADHD treatment
|
10/05/2010
|
Aridol Powder for Inhalation
|
mannitol
|
Assessment of bronchial hyperresponsiveness in patients without clinically apparent asthma
|
New indication in patients 6 years and olderEfficacy assessed in a total of 246 children and adolescents 6 to 17 years in 2 clinical trialsBronchial challenge testing should not be performed in children < 6 years due to their inability to provide reliable spirometric measurements Adverse events similar to adultsInformation on adverse events and clinical studiesNew indication, dosage form, and route of administration
|
Labeling
|
|
P
|
|
|
Pharmaxis
|
|
FALSE'
|
Diagnostic aid
|
10/21/2010
|
Lo Loestrin Fe
|
norethindrone acetate/ ethinyl estradiol
|
Prevention of pregnancy
|
Safety and efficacy have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents <18 years and for users e18 years Use before menarche is not indicatedNew dose and dosing regimen
|
Labeling
|
|
P
|
|
|
Warner Chilcott
|
|
TRUE'
|
Contraceptive
|
10/29/2010
|
Afinitor
|
everolimus
|
Treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis
|
Approved for treatment of patients with SEGA associated with TS An open-label, single-arm safety and efficacy trial was conducted in 28 patients 3-34 years with SEGA associated with TS Afinitor has not been studied in patients with SEGA < 3 years of ageMost common adverse reactions (incidence e30%) were stomatitis, upper respiratory tract infection, sinusitis, otitis media, and pyrexiaDose reduction and/or treatment interruption may be needed to manage adverse drug reactions Information on starting dose, therapeutic drug monitoring, clinical trial, and adverse reactions New indication
|
Labeling
|
B
|
|
|
|
Novartis
|
|
FALSE'
|
Antineoplastic
|
11/02/2010
|
Ofirmev
|
acetaminophen
|
Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever
|
The safety and effectiveness of Ofirmev for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Ofirmev in adults. Additional safety and PK data was collected in 355 from premature neonates to adolescents. The effectiveness of Ofirmev for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.The PK exposure of Ofirmev observed in children and adolescents is similar to adults, but higher in neonates and infants. Dosing simulations from PK data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a PK exposure similar to that observed in children age 2 years and olderMost common adverse reactions in pediatric patients were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.Information on dosing, clinical studies, adverse reactions and PK parametersNew dosage form and route of administration
|
Labeling
|
|
P
|
|
|
Cadence
|
|
FALSE'
|
Analgesic; Antipyretic
|
11/10/2010
|
Vyvanse Capsules
|
lisdexamfetamine
|
ADHD
|
Expanded indication to include adolescent patients ages13-17 years; previously approved for use in 6-12 years Most common adverse reactions were decreased appetite, insomnia, and decreased weightInformation on clinical trial, adverse reactions
|
Labeling
|
|
P
|
|
|
Shire
|
|
FALSE'
|
CNS Stimulant
|
11/12/2010
|
Synercid
|
quinopristin/dalfopristin
|
Postmarketing study
|
Labeling updated to revise pediatric dosing in 12 to less than 18 years. No dosing recommendations in pediatric patients less than 12 years Postmarketing study
|
Labeling
|
|
|
|
R
|
King Pharmaceuticals
|
|
FALSE'
|
Antibiotic
|
11/19/2010
|
Moxeza Ophthalmic Solution
|
moxifloxacin
|
Bacterial conjunctivitis
|
Approved for use in patients 4 months and olderThe safety and effectiveness have not been established in patients <4 months of age There is no evidence that the ophthalmic administration of moxifloxacin has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animalsInformation on clinical study, adverse reactionsNew dosage form
|
Labeling
|
|
P
|
|
|
Alcon
|
|
FALSE'
|
Antibiotic
|
12/15/2010
|
Uroxatral
|
alfuzosin
|
Elevated detrusor leak point pressure of neurologic origin
|
Uroxatral is not indicated for use in the pediatric populationEfficacy was not demonstrated in a randomized, double-blind, placebo-controlled, efficacy and safety trial conducted in 172 patients ages 2 to 16 years using pediatric formulations
|
Labeling
|
B
|
|
|
|
Sanofi Aventis
|
09/07/2010
|
FALSE'
|
Urology
|
12/21/2010
|
INOmax
|
nitric oxide
|
Prevention of bronchopulmonary dysplasia
|
INOmax is not indicated for prevention of BPD in preterm neonates d 34 weeks gestational age.Efficacy for the prevention of BPD in preterm infants was not established in three ldouble-blind, placebo-controlled clinical trials in a total of 2,149 preterm infants Information on clinical trials, adverse reaction
|
Labeling
|
B
|
|
|
|
INO Therapeutics
|
11/02/2010
|
FALSE'
|
Pulmonary vasodilator
|
12/22/2010
|
GARDASIL
|
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
|
Prevention of anal cancer caused by HPV types 16 and 18, and prevention of anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types included in the vaccine
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Merck
|
|
FALSE'
|
Preventive Vaccine
|
01/18/2011
|
Natroba
|
spinosad
|
Treatment of head lice infestation in patients 4 years of age and older
|
Safety and effectiveness have been established in pediatric patients 4 years of age and older Safety in pediatric patients < 4 years has not been established. Not recommended in pediatric patients< 6 months because of the potential for increased systemic absorptionNatroba contains benzyl alcohol which has been associated with serious adverse reactions and death in neonates and low birth-weight infants. Premature and low-birth weight infants, as well as patients receiving high dosages, may be more likely to develop toxicityInformation on clinical trials, adverse reactionsNew drug
|
Labeling
|
|
P
|
|
|
ParaPRO
|
|
FALSE'
|
Pediculocide, topical
|
01/19/2011
|
Nasonex
|
mometasone
|
Treatment of nasal polyps
|
Safety and effectiveness for the treatment of nasal polyps in children < 18 years have not been establishedA trial in pediatric patients 6 to 17 years did not support the efficacy of Nasonex Nasal Spray in the treatment of nasal polyps The adverse events were similar to adultsInformation on clinical tria
|
Labeling
|
|
P
|
|
|
Schering Plough
|
|
TRUE'
|
Anti-inflammatory, topical
|
01/28/2011
|
MENVEO
|
Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
|
Active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Novartis
|
|
FALSE'
|
Preventive Vaccine
|
02/03/2011
|
Makena
|
hydroxyprogesterone caproate
|
Reduce the risk of preterm birth
|
Safety and effectiveness in pediatric patients <16 years have not been establishedA small number of women < 18 years were studied; safety and efficacy are expected to be the same in women aged 16 years and above as for users 18 years and olderInformation on clinical trial
|
Labeling
|
|
P
|
|
|
Hologic, Inc.
|
|
TRUE'
|
Progestin
|
02/17/2011
|
Hizentra
|
Globulin Subcutaneous (Human), 20% Liquid
|
Postmarketing study
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
CSL Behring AG
|
|
FALSE'
|
Immune Serum
|
02/25/2011
|
Intuniv
|
guanfacine
|
Adjunctive treatment with long-acting oral psychostimulants for the treatment of ADHD
|
Approved for use as adjunctive therapy with stimulants for the treatment of ADHD in pediatric patients 6 years and olderInformation on adverse reactions and clinical trialNew indicatio
|
Labeling
|
|
P
|
|
|
Shire
|
|
FALSE'
|
Non-stimulant ADHD treatment
|
03/14/2011
|
Gadavist
|
gadobutrol
|
Detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system
|
Safety and efficacy have been established in children 2 - 17 yearsSafety and effectiveness have not been established in children <2 yearsInformation on dosing, adverse events, pharmacokinetics, and clinical trials
|
Labeling
|
|
P
|
|
|
Bayer
|
|
FALSE'
|
Medical imaging
|
03/17/2011
|
Alimta
|
pemetrexed disodium
|
Refractory and recurrent solid tumors, including osteosarcoma, Ewing sarcoma/peripheral PNET, rhabdomyosarcoma, and neuroblastoma
|
Efficacy in pediatric patients has not been demonstratedNo responses were observed among the 72 patients in the Phase 2 trialInformation on dosing, clinical trial, adverse events and pharmacokinetics
|
Labeling
|
B
|
|
|
|
Lilly
|
12/03/2010
|
FALSE'
|
Antineoplastic
|
04/06/2011
|
Invega
|
paliperidone
|
Treatment of schizophrenia
|
Extended treatment of schizophrenia indication from adults to adolescents 12-17 yearsSafety and effectiveness for the treatment of schizophrenia in patients < 12 years have not been established. Safety and effectiveness for the treatment of schizoaffective disorder in patients < 18 years have not been studied In the adolescent schizophrenia trial, there was no clear enhancement to efficacy at escalation to higher doses (e.g., 6 mg for patients weighing less than 51 kg and 12 mg for patients weighing 51 kg or greater) while adverse events were dose-relatedIn the 6-week, placebo-controlled study in adolescents with schizophrenia, the incidences of extrapyramidal symptoms related adverse events showed a similar dose-related pattern to those in the adult studies. There were notably higher incidences of dystonia, hyperkinesia, tremor, and parkinsonism in adolescents as compared to the adult studiesAdverse reactions in the adolescent trial included somnolence, akathisia, tremor, dystonia, cogwheel rigidity, anxiety, weight gain, and tachycardiaInformation on dosing, adverse events, clinical trial
|
Labeling
|
|
|
B, P
|
|
Ortho McNeil
|
01/05/2011
|
FALSE'
|
Antipsychotic
|
04/15/2011
|
Actemra
|
tocilizumab
|
Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA)
|
Approved for the treatment of active SJIA in patients 2 years and olderSafety and effectiveness in pediatric patients with conditions other than SJIA have not been establishedChildren < 2 years have not been studiedInterruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopeniaLiver enzyme elevation, low neutrophil count, low platelet count and lipid elevations are noted with Actemra treatment in the SJIA population. The most common adverse events Actemra treated patients in the controlled portion of the study were upper respiratory tract infection, headache, nasopharygitis and diarheaInformation on dosing, lab parameters, adverse reactions, clinical trialNew indication
|
Labeling
|
|
P
|
|
|
Genentech
|
|
FALSE'
|
Biological response modifier
|
04/22/2011
|
Menactra
|
Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine)
|
Active immunization of individuals 9 months through 55 years of age for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Sanofi Pasteur
|
|
FALSE'
|
Preventive Vaccine
|
04/25/2011
|
Lamictal XR
|
lamotrigine
|
Monotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug (AED)
|
Approved for conversion to monotherapy in patients e13 years of age with partial seizures receiving treatment with a single antiepileptic drug (AED).Safety and effectiveness have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from two or more concomitant AEDsInformation on conversion to monotherapy, adverse reactions, clinical trialNew indication
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Anticonvulsant
|
04/29/2011
|
Nexium IV
|
esomeprazole
|
Treatment of Gastroesophageal Reflux Disease (GERD) with erosive esophagitis
|
Extended indication from adults to pediatric patients 1 month to 17 years Use in pediatric patients 1 month to 17 years is supported by studies in adults, and PK and PD studies performed in pediatric patientsEffectiveness has not been established in patients less than 1 month of ageInformation on dosing, adverse reactions, pharmacokinetics and clinical trialPostmarketing study
|
Labeling
|
|
P
|
|
|
AstraZeneca
|
|
FALSE'
|
Antiulcerative
|
04/29/2011
|
Kytril Injection
|
granisetron hydrochloride
|
Prevention of postoperative nausea and vomiting
|
Safety and efficacy have not been established in pediatric patients for the prevention of postoperative nausea and vomiting (PONV)Due to the lack of efficacy and the QT prolongation observed in this trial, use for the prevention of PONV in children is not recommendedInformation on postmarketing clinical trial, adverse reactionsPostmarketing PREA required study
|
Labeling
|
|
P
|
|
|
Hoffman- LaRoche
|
|
FALSE'
|
Antiemetic
|
05/06/2011
|
Plavix
|
clopidogrel bisulfate
|
Reduction of the incidence of thrombosis in children with systemic to pulmonary artery shunts for palliation of cyanotic congenital heart disease
|
Safety and effectiveness in pediatric populations have not been establishedA randomized, placebo-controlled trial did not demonstrate a clinical benefit in neonates and infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt.
|
Labeling
|
B
|
|
|
|
Sanofi Aventis
|
01/20/2011
|
FALSE'
|
Platelet inhibitor
|
05/17/2011
|
Faslodex Injection
|
fulvestrant
|
Use in girls with progressive precocious puberty associated with McCune-Albright Syndrome
|
Efficacy has not been demonstrated in girls with McCune-Albright Syndrome associated with progressive precocious pubertyInformation on dosing, adverse reactions, pharmacokinetics and clinical trial
|
Labeling
|
B
|
|
|
|
AstraZeneca
|
02/01/2011
|
FALSE'
|
Estrogen lowering agent
|
06/01/2011
|
KEDBUMIN
|
Albumin (Human)
|
Hypovolemic shock, Hypoalbuminemia, Prevention of central volume depletion after paracentesis due to cirrhotic ascites, Ovarian Hyperstimulation Syndrome (OHSS), Adult Respiratory Distress Syndrome (ARDS), Burns, Hemodialysis patients undergoing long term dialysis, Patients who cannot tolerate substantial volumes of salt solution, Priming solution for cardiopulmonary bypass
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Kedrion, S.p.A.
|
|
TRUE'
|
albumin
|
06/10/2011
|
Creon
|
pancrelipase
|
Postmarketing study
|
New dosage strength of 3,000 USP lipase units to allow for dosing in infants less than 12 monthsPostmarketing study
|
Labeling
|
|
P
|
|
|
Abbott
|
|
TRUE'
|
Pancreatic enzyme
|
06/15/2011
|
Zenpep
|
pancrelipase
|
Postmarketing study
|
New dosage strength of 3,000 USP lipase units to allow for dosing in infants less than 12 monthsPostmarketing study
|
Labeling
|
|
P
|
|
|
Eurand
|
|
TRUE'
|
Pancreatic enzyme
|
07/08/2011
|
Truvada
|
emtricitabine/tenofovir disoproxil fumarate
|
Treatment of HIV-1 infection in adolescents
|
* Expanded indication from adults to pediatric patients 12 years and older. * Safety and efficacy have not been established in pediatric patients less than 12 years or weighing less than 35 kg. * Truvada should only be administered to pediatric patients 12 years and older with body weight greater than or equal to 35 kg. * Information on dosing, adverse reactions, PK and clinical trial. * Postmarketing study
|
|
|
P
|
|
|
Gilead
|
|
FALSE
|
Antiviral
|
07/15/2011
|
Topamax
|
topiramate
|
Monotherapy for partial onset or primary generalized tonic-clonic seizures
|
Expanded age range down to 2 years; previously approved for monotherapy for partial onset or primary generalized tonic-clonic seizures in patients10 years and older Information on weight based dosing in 2 to < 10 yearsPostmarketing study
|
Labeling
|
|
P
|
|
|
Janssen
|
|
FALSE'
|
Anticonvulsant
|
07/19/2011
|
CERVARIX
|
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
|
Postmarketing Study
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline Biologicals
|
|
FALSE'
|
Preventive Vaccine
|
07/22/2011
|
GAMMAGARD LIQUID
|
Immune Globulin Infusion (Human)
|
Treatment of patients with primary immunodeficiency associated with defects in humoral immunity in adults and pediatric patients two years of age or older
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Baxter
|
|
FALSE'
|
Immunomodulator
|
08/22/2011
|
Copegus and PEGASYS
|
ribavirin and peginterferon alfa-2a
|
Treatment of chronic hepatitis C in patients 5 to 17 years of age
|
Extended indication from adults to pediatric patients 5-17 yearsSafety and effectiveness of PEGASYS, alone or in combination with COPEGUS in patients < of 5 years have not been establishedPediatric patients treated with PEGASYS plus COPEGUS combination therapy showed a delay in weight and height increases after 48 weeks of therapy compared with baseline. At the end of 2 years follow-up after treatment, most patients returned to baseline normative growth curve percentiles for weight and heightDecreases in hemoglobin, neutrophils and platelets may require dose reduction or permanent discontinuation from treatment If toxicities occur which may be related to PEGASYS or COPEGUS administration, the dose of one or both can be modifiedAdverse reactions were similar to adultsInformation on dosing, clinical trial, and adverse reactions
|
Labeling;href="http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5213lbl.pdf">Labeling
|
|
P
|
|
|
Hoffman- LaRoche
|
|
FALSE'
|
Antiviral
|
10/17/2011
|
Reyataz
|
atazanavir
|
Treatment of HIV - 1 infection
|
Revised pediatric dosing; Unified dosing for treatment-naive and treatment experienced patients and extended the use of ATV/RTV to treatment-experienced patients weighing 15 to 25 kgNew dosing regimen
|
Labeling
|
|
|
B, P
|
|
Bristol-Myers Squibb
|
|
FALSE'
|
Antiviral
|
10/18/2011
|
Ixempra Kit
|
ixabepilone
|
Advanced or refractory solid tumors
|
The effectiveness in pediatric patients has not been established Ixempra was evaluated in one Phase 1 and one Phase 2 trial Adverse reactions were similar to adults, and no new safety signals were identified
|
Labeling
|
B
|
|
|
|
Bristol-Myers Squibb
|
04/05/2011
|
FALSE'
|
Antineoplastic
|
11/09/2011
|
Chantix
|
varenicline
|
Smoking cessation
|
Safety and effectiveness of Chantix in pediatric patients have not been established; Chantix is not recommended for use in patients < 18 years of ageInformation on single and multiple-dose pharmacokinetics of varenicline have been investigated in pediatric patients 12 - 17 years Postmarketing study
|
Labeling
|
|
|
B, P
|
|
Pfizer
|
|
FALSE'
|
Smoking cessation
|
11/10/2011
|
HEMACORD
|
hematopoietic progenitor cells, cord blood
|
For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
New York Blood Center, Inc.
|
|
FALSE'
|
Somatic Cell
|
12/14/2011
|
Advate
|
Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method
|
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with hemophilia A
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Baxter
|
|
|
Antihemophilic Factor
|
12/15/2011
|
Nexium
|
esomeprazole
|
Erosive esophagitis due to acid-mediated gastroesophageal reflux disease
|
Expanded age range to include pediatric patients 1 month to <1 year. Previously approved in 1-17 years. Use in 1 month to <1 year is supported by extrapolation of studies for adults and safety, pharmacokinetic, and pharmacodynamic studies performed in pediatric patients Safety and effectiveness have not been established in neonatesInformation on weight-based dosing, adverse reactions, clinical study
|
Labeling
|
|
|
B, P
|
|
AstraZeneca
|
|
FALSE'
|
Antiulcerative
|
12/16/2011
|
Prezista
|
darunavir
|
Treatment of HIV-1 infection in adults and pediatric patients 3 years of age and older and weighing at least 10 kg
|
Expanded indication to pediatric patients 3 years and older weighing at least 10 kg; previously approved for use in 6 years and olderDo not use in pediatric patients < 3 years of ageInformation on dosing, adverse reactions, pharmacokinetics and clinical trialNew formulation
|
Labeling
|
|
|
B, P
|
|
Tibotec
|
06/07/2011
|
FALSE'
|
Antiviral
|
12/16/2011
|
Maxalt and Maxalt-MLT
|
rizatriptan
|
Treatment of migraine
|
Expanded indication to include pediatric patients from 6 - 17 years. Safety and effectiveness in this age group was established in an adequate and well-controlled trial.Safety and effectiveness in pediatric patients under 6 years of age have not been established.Efficacy and safety of treatment with more than one dose of Maxalt within 24 hours in patients 6 to 17 years of age have not been establishedMaxalt should not be prescribed to propranolol-treated pediatric patients who weigh < 40 kg (88 lb)The incidence of adverse reactions in the pediatric clinical trial was similar between treatment and placebo groups. The adverse reaction pattern in pediatric patients is expected to be similar to adultsHallucination, abnormal coordination, disturbance in attention, and presyncope occurred infrequently in pediatric patients in the clinical trial Information on dosing, adverse reactions, clinical trial, and overdose
|
Labeling
|
B
|
|
|
|
Merck
|
09/20/2011
|
FALSE'
|
Antimigraine
|
12/16/2011
|
Keppra
|
levetiracetam
|
Adjunctive therapy in the treatment of partial onset seizures
|
Expanded indication to include pediatric patients from 1 month - <4 years; previously approved for use in 4 years and olderIn pediatric patients 1 month - < 4 years of age, 17% experienced psychotic symptoms compared to 5% on placebo; irritability was reported in 11.7% of the Keppra-treated patients compared to 0% of placebo patientsInformation on dosing, clinical trial, adverse reactions
|
Labeling
|
|
|
B, P
|
|
UCB
|
06/03/2008
|
TRUE'
|
Anticonvulsant
|
12/21/2011
|
Isentress
|
raltegravir
|
In combination with other antiretroviral agents for the treatment of HIV-1 infection
|
Isentress Chewable tablets: Expanded indication from adults to pediatric patients 2 - < 12 years and weighing at least 10kg Isentress Tablets: Expanded indication from adults to pediatric patients 6-18 years Safety and effectiveness in patients <2 years have not been establishedBecause the formulations are not bioequivalent, do not substitute chewable tablets for the 400 mg film-coated tablet Safety profile similar to that observed in adults Information on dosing, adverse reactions, clinical trial and PK parameters New dosage form
|
Labeling
|
|
|
B, P
|
|
Merck
|
|
FALSE'
|
Antiviral
|
01/18/2012
|
Viread
|
tenofovir disoproxil fumarate
|
Treatment of HIV infection in combination with other antiretroviral agents
|
Viread tablets: Expanded the indication from adults to pediatric patients 2 - < 12 years, weighing greater than or equal to 17 kg, who can swallow an intact tablet; tablet previously approved for use in 12 years and older Viread Oral Powder: Expanded the indication from adults to pediatric patients 2 years of age and older Safety and effectiveness in patients <2 years have not been established Viread oral powder should be mixed in a container of soft food not requiring chewing (e.g., applesauce, baby food, yogurt) and ingested immediately to avoid a bitter taste Adverse reactions were similar to those observed in adults Postmarketing study, new dosage form
|
Labeling
|
|
|
B, P
|
|
Gilead
|
09/06/2011
|
FALSE'
|
Antiviral
|
01/25/2012
|
TISSEEL
|
Fibrin Sealant
|
Hemostasis: An adjunct to hemostasis in patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: An adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Baxter
|
|
|
Wound healing
|
02/07/2012
|
Sklice
|
ivermectin
|
Topical treatment of head lice infestations
|
Safety and effectiveness in children 6 months and older have been established Safety has not been established in pediatric patients < 6 months. Sklice Lotion is not recommended in pediatric patients <6 months of age because of the potential increased systemic absorption and risk of ivermectin toxicityInformation on dosage and administration, adverse reactions, pharmacokinetics and clinical trialsNew drug
|
Labeling
|
|
P
|
|
|
Sanofi-Topaz, Inc.
|
|
|
Pediculocide, topical
|
02/09/2012
|
Famvir
|
famciclovir
|
Recurrent herpes labialis
|
Efficacy has not been established in pediatric patients for the treatment of recurrent herpes labialis Information on an open label PK, safety and efficacy study in children 12 to <18 years with recurrent herpes labialis added to Pediatric Use subsection of labelingPostmarketing study
|
Labeling
|
|
P
|
|
|
Novartis
|
|
|
Antiviral
|
02/29/2012
|
FluMist Quadrivalent
|
Influenza Vaccine Live, Intranasal
|
Active immunization for the prevention of disease caused by influenza
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
MedImmune
|
|
FALSE'
|
Vaccine
|
03/01/2012
|
Ultresa
|
pancrelipase
|
Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions
|
Safety and efficacy assessed in 2 studies that included patients 7--17 years Safety and efficacy of pancreatic enzyme products with different formulations of the same active ingredient for use in children have been described in medical literature and through clinical experience High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age Adverse reactions similar to adults Use in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended Children > 12 months and < 4 years, weighing < 14 kg and children e 4 years, weighing < 28 kg should not be dosed with this product because capsule dosage strengths cannot adequately provide dosing for these children Capsule should be swallowed whole. Capsule and contents should not be crushed or chewed. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce and swallowed immediately Information on dosing and clinical studies Not interchangeable with other pancrelipase products New drug
|
Labeling
|
|
P
|
|
|
Aptalis Pharma U.S., Inc
|
|
|
Pancreatic enzyme
|
03/14/2012
|
Natazia
|
estradiol valerate and estradiol valerate/dienogest
|
Treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception
|
Safety and efficacy have been established in women of reproductive age. Safety and efficacy for post pubertal adolescents < 18 are expected to be the same as for 18 years and older Use of this product before menarche is not indicated New indication
|
Labeling
|
|
P
|
|
|
Bayer
|
|
|
Contraceptive
|
03/23/2012
|
QNASL
|
beclomethasone dipropionate
|
Treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis
|
Safety and effectiveness in children 12 years and older have been established Safety and effectiveness in <12 years have not been established Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Routinely monitor the growth of pediatric patients receiving QNASL Nasal Aerosol The potential for QNASL Nasal Aerosol to cause reduction in growth velocity in susceptible patients or when given at higher than recommended dosages cannot be ruled out Information on safety, adverse events and clinical trials New dosage form
|
Labeling
|
|
P
|
|
|
Teva
|
|
|
Anti-inflammatory, topical
|
03/26/2012
|
Singulair Oral Granules, Tablets, and Chewable Tablets
|
montelukast
|
Prevention of exercise-induced bronchoconstriction
|
Expanded indication to include pediatric patients from 6 - 14 years; previously approved for use in 15 years and older Efficacy for prevention of EIB in patients < 6 years of age has not been established Information on clinical trial, and dosing Postmarketing study
|
Labeling
|
|
P
|
|
|
Merck
|
|
FALSE'
|
Antiasthmatic; antiallergy
|
03/26/2012
|
Intelence
|
etravirine
|
Treatment of HIV-1 infection in treatment-experienced patients in combination with other antiretroviral agents
|
Expanded the indication from adults to pediatric patients 6 years and older Safety and efficacy have not been established in children < 6 years or in treatment naive adult or pediatric patients Adverse reactions were similar to those observed in adults except for rash which was observed more frequently in pediatric patients (15%) compared to adults (10%)Intelence tablet(s) should be swallowed whole. Patients who are unable to swallow the Intelence tablet(s) whole may disperse the tablet(s) in a glass of water Information on dosing in pediatric patients 6 - <18 years and weighing at least 16 kg, dispersing tablet in water, adverse reactions, and clinical trial Postmarketing study
|
Labeling
|
|
|
B,P
|
|
J&J
|
|
FALSE'
|
Antiviral
|
04/27/2012
|
Levaquin
|
levofloxacin
|
Treatment and prophylaxis of plague due to Yersinia pestis
|
Approved for the treatment and prophylaxis of plague due to Yersinia pestis in patients 6 months and older Efficacy studies could not be conducted in humans with pneumonic plague for ethical and feasibility reasons. Approval of this indication was based on an efficacy study conducted in animals Safety and effectiveness in pediatric patients < 6 months have not been established Information on animal study New indication
|
Labeling
|
|
P
|
|
|
Janssen
|
|
FALSE'
|
Antibiotic
|
04/27/2012
|
Lexiva
|
fosamprenavir
|
Treatment of HIV-1 infection
|
Expanded indication to include pediatric patients at least 4 weeks - <2 years; previously approved for use in 2 18 years The PK, safety, tolerability, and efficacy in pediatric patients < 4 weeks have not been established Dosing of Lexiva plus ritonavir is not recommended for protease inhibitor-experienced pediatric patients <6 months of age; data do not support twice-daily dosing of Lexiva without ritonavir in pediatric patients <2 years Weight-adjusted apparent clearance was higher in children < 4 years, suggesting that younger children require higher mg per kg dosing of Lexiva Vomiting and neutropenia were more frequent in pediatrics than in adults. Other adverse reactions were similar to adults Information on dosing, clinical trials, PK and adverse reactions New dosage regimen for patients at least 4 weeks - < 6 years; Postmarketing study
|
Labeling
|
|
|
B, P
|
|
ViiV Healthcare
|
01/10/2012
|
FALSE'
|
Antiviral
|
05/01/2012
|
Dymista
|
azelastine hydrochloride and fluticasone proprionate
|
Relief of symptoms of seasonal allergic rhinitis
|
Safety and effectiveness have been established in 3 clinical trials in patients 12 years and older Safety and effectiveness in pediatric patients < 12 years have not been established Intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. The growth of pediatric patients receiving intranasal corticosteroids, including Dymista, should be monitored routinely Information on dosing, adverse reactions, and clinical trials New drug
|
Labeling
|
|
P
|
|
|
|
|
FALSE'
|
Antiasthmatic;antiallergy
|
05/12/2012
|
Voluven
|
6% Hydroxyethyl Starch 130/0.4 In 0.9% Sodium Chloride Injection
|
Plasma volume substitute for treatment and prophylaxis of hypovolemia
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Fresenius Kabi Norge AS
|
|
FALSE'
|
Coagulant
|
05/17/2012
|
Pertzye
|
pancrelipase
|
Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions
|
Safety and efficacy assessed in a clinical trial that included 10 patients 8 - 17 years Safety and efficacy of pancreatic enzyme products with different formulations of the same active ingredient for use in children have been described in medical literature and through clinical experience Use in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age Capsule should be swallowed whole. Capsule and contents should not be crushed or chewed For patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce and swallowed immediately Not interchangeable with other pancrelipase products New drug
|
Labeling
|
|
P
|
|
|
|
|
FALSE'
|
Pancreatic enzyme
|
05/30/2012
|
Torisel
|
temsirolimus
|
Advanced recurrent/refractory solid tumors
|
Effectiveness in pediatric patients has not been established Torisel was studied in 59 patients 1 - 17 years and 12 patients 18 to 21 years in a phase 1-2 safety and exploratory pharmacodynamic study Adverse reactions were similar to those observedd in adults Information on dosing, clinical trials and PK parameters
|
Labeling
|
B
|
|
|
|
|
|
FALSE'
|
Antineoplastic
|
06/14/2012
|
MENHIBRIX
|
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
|
Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b
|
See Package Insert for new information on biologics
|
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm122938.htm
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Preventive Vaccine
|
06/26/2012
|
Treanda
|
bendamustine hydrochloride
|
Relapsed or refractory acute leukemia
|
Effectiveness in pediatric patients has not been established Treanda was evaluated in a Phase 1/2 trial in pediatric patients with leukemia The safety profile in pediatric patients was consistent with that seen in adults, and no new safety signals were identified Information on dosing, clinical trials and PK parameters
|
Labeling
|
B
|
|
|
|
|
|
FALSE'
|
Antineoplastic
|
08/02/2012
|
Risperdal
|
risperidone
|
Postmarketing study
|
Information on postmarketing clinical study of a lower than recommended dose for irritability associated with autistic patients in patients 5 to 17 years Postmarketing study
|
Labeling
|
|
P
|
|
|
Janssen
|
|
FALSE'
|
Antipsychotic
|
08/16/2012
|
Viread
|
tenofovir disoproxil fumarate
|
Treatment of chronic hepatitis B
|
Expanded the indication from adults to pediatric patients 12 - < 18 years of age, weighing at least 35kSafety and efficacy in pediatric patients with chronic hepatitis B < 12 years old or weighing < 35 kg have not been established In a clinical trial in pediatric patients 12 - <18 years, the mean rate of bone mineral density gain was less in Viread-treated patients compared to placeboInformation on dosing, adverse reactions, and clinical trial Postmarketing study
|
Labeling
|
|
P
|
|
|
Gilead
|
|
FALSE'
|
Antiviral
|
08/29/2012
|
Afinitor Disperz
|
everolimus
|
Treatment of subependymal giant cell astrocytoma (SEGA) in patients with tuberous sclerosis complex (TSC)
|
Approved for patients 1 year and older with TSC for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected The safety and effectiveness of Afinitor Tablets and Afinitor Disperz have not been established in pediatric patients with renal angiomyolipoma with TSC in the absence of SEGA The effectiveness in pediatric patients with SEGA was demonstrated in two clinical trial The long term effects of Afinitor on growth and pubertal development are unknown Information on starting dose, therapeutic drug monitoring, clinical trial, and adverse reactions New formulation
|
Labeling
|
B
|
|
|
|
Novalar Pharmaceuticals, Inc.
|
07/10/2012
|
FALSE'
|
Antineoplastic
|
08/30/2012
|
Revatio
|
sildenafil
|
Treatment of pulmonary arterial hypertension
|
Use of Revatio, particularly chronic use, is not recommended in children In a double-blind, placebo-controlled, dose-ranging study, 234 pediatric patients with PAH 1 - 17 years were randomized based on body weight to three dose levels of Revatio, or placebo, for 16 weeks. No patients died during the 16-week study In a long-term trial, an increase in mortality with increasing dose was observed. Deaths were first observed after about 1 year and causes of death were typical of patients with PAH Information on safety, and clinical trials
|
Labeling
|
|
|
B, P
|
|
Pfizer
|
02/09/2012
|
FALSE'
|
Peripheral Vasodilator
|
09/21/2012
|
Venofer
|
iron sucrose
|
Treatment of iron deficiency anemia in patients with chronic kidney disease (CKD)
|
Expanded the indication from adults to pediatric patients 2 years and olderSafety and effectiveness for iron maintenance treatment in pediatric patients 2 years of age and older with dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy were studied Safety and effectiveness for iron replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD have not been established Venofer has not been studied in patients < 2 years The mean Cmax and AUC values were 1.42- and 1.67-fold higher than dose adjusted adult Cmax and AUC values The most common treatment-emergent adverse reactions were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), renal transplant (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%) Information on dosing, adverse reactions, pharmacokinetics, and clinical trial Postmarketing study
|
Labeling
|
|
P
|
|
|
Luitpold Pharmaceuticals
|
|
FALSE'
|
Iron Replacement
|
09/27/2012
|
QUILLIVANT XR
|
methylphenidate hydrochloride
|
Treatment of Attention Deficit Hyperactivity Disorder
|
Safety and effectiveness have been established in pediatric patients ages 6 - 17 years Use in pediatric patients 6 - 12 years of age is supported by adequate and well-controlled studies. Use in 12 - 17 year olds is supported by the adequate and well-controlled studies of Quillivant XR in younger pediatric patients and additional pharmacokinetic data in adolescents, with safety information from other methylphenidate products The long-term efficacy of methylphenidate in pediatric patients has not been established Safety and efficacy in pediatric patients below the age of 6 years have not been established Growth should be monitored during treatment with stimulants, including Quillivant XR. Children who are not growing or gaining weight as expected may need to have their treatment interrupted Information on adverse reactions, pharmacokinetics and clinical tria lNew dosage form
|
Labeling
|
|
P
|
|
|
NextWave Pharmaceuticals, Inc.
|
|
FALSE'
|
CNS Stimulant
|
10/10/2012
|
Lunesta
|
eszopiclone
|
Attention-Deficit Hyperactivity Disorder associated insomnia
|
Safety and effectiveness have not been established in pediatric patientsLunesta failed to demonstrate efficacy in a 12-week controlled study of 483 pediatric patients 6-17 years with insomnia associated with ADHD Psychiatric and nervous system disorders comprised the most frequent treatment emergent adverse reactions observed with Lunesta versus placebo and included dysgeusia (9% vs. 1%), dizziness (6% vs. 2%), hallucinations (2% vs. 0%) and suicidal ideation (0.3% vs. 0%) Information on dose, adverse reactions clinical trial and juvenile animal studies
|
Labeling
|
|
|
B,P
|
|
Sunovion Pharmaceuticals
|
06/29/2012
|
FALSE'
|
Hypnotic
|
10/12/2012
|
Bethkis
|
tobramycin
|
Management of cystic fibrosis patients with P. aeruginosa
|
Safety and efficacy have been established in adults and children 6 years and older Safety and efficacy have not been studied in pediatric patients less than 6 years Use caution in patients with known or suspected auditory or vestibular dysfunction or renal dysfunction. Bronchospasm can occur with inhalation of tobramycin Information on dose, adverse reactions, and clinical trials New drug
|
Labeling
|
|
P
|
|
|
Chiesi Pharmaceuticals, Inc.
|
|
FALSE'
|
Antibiotic, topical
|
10/18/2012
|
Cymbalta
|
duloxetine hydrochloride
|
Treatment for Major Depressive Disorder (MDD)
|
Efficacy was not demonstrated in two 10-week, placebo-controlled trials with 800 pediatric patients with MDD, age 7-17 Duloxetine has not been studied in pediatric patients less than 7 years Decreased appetite and weight loss have been observed in association with the use of SSRIs and SNRIs. Pediatric patients treated with duloxetine in MDD clinical trials experienced a 0.2 kg mean decrease in weight at 10-weeks, compared with a mean weight gain of approximately 0.6 kg in placebo-treated patients. The proportion of patients who experienced a clinically significant decrease in weight (>3.5%) was greater in the duloxetine group than in the placebo group (11% and 6%, respectively). Subsequently, over the six-month uncontrolled extension period, most duloxetine treated patients trended toward recovery to their expected baseline weight. Perform regular monitoring of weight and growth in children and adolescents treated with an SNRI such as duloxetine In the 2 pediatric MDD studies, the safety findings were consistent with the known safety and tolerability profile for duloxetine Information on clinical trial, pharmacokinetics, and juvenile animal study
|
Labeling
|
|
|
B,P
|
|
Lilly
|
07/10/2012
|
FALSE'
|
Antidepressant
|
10/19/2012
|
Oxtellar XR
|
oxcarbazepine
|
Adjunctive therapy of partial seizures
|
Safety and effectiveness in pediatric patients ages 6 - 16 years with partial onset seizures is supported by an adequate and well-controlled short term safety and efficacy study in adults that included pharmacokinetic sampling, a pharmacokinetic study in pediatric patients ages 4 - 16 years, and safety and efficacy studies with the immediate-release formulation in adults and pediatric patients Oxtellar XR is not approved for pediatric patients < 6 years because the size of the tablets are inappropriate for younger children, and has not been studied in patients < 4 years Information on dosing, adverse reactions, and pharmacokinetics New dosage form
|
Labeling
|
|
P
|
|
|
Supernus Pharmaceuticals
|
|
FALSE'
|
Anticonvulsant
|
10/22/2012
|
Fycompa
|
perampanel
|
Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy
|
The safety and efficacy was established by 3 double blind, placebo-controlled studies which included 72 pediatric patients 12 - 16 years old exposed to perampanel The safety and effectiveness in pediatric patients <12 years old have not been established Most common adverse reactions in adult and pediatric patients include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, gait disturbance, and balance disorder Information on clinical trials, dosing, adverse reactions, and pharmacokinetics New drug
|
Labeling
|
|
P
|
|
|
Eisai Medical Research
|
|
FALSE'
|
Anticonvulsant
|
11/08/2012
|
VIRAMUNE XR
|
nevirapine
|
Treatment of HIV-1 infection
|
Approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in children 6 - < 18 years. Use in pediatric patients 6 - < 18 years is based on pharmacokinetic, safety, and antiviral activity data from an open-label trial and supported by previous demonstration of efficacy in adults. Not recommended for children < 6 years since clinical trial did not provide sufficient pharmacokinetic data for children 3 - < 6 years to support the use in this age group. Furthermore, not recommended for children < 3 years because they are not able to swallow tablets. Viramune XR tablets must be swallowed whole and must not be chewed, crushed, or divided. Children should be assessed for their ability to swallow tablets before prescribing No recommendations can be made regarding substitution of four VIRAMUNE XR 100 mg tablets for one VIRAMUNE XR 400 mg tablet Pediatric patients may be dosed using Viramune XR 400 mg or 100 mg tablets. Viramune XR is dosed based on a patients body surface area (BSA). All pediatric patients must initiate therapy with immediate-release Viramune at a dose not to exceed 200 mg per day, administered once daily for the first 14 days because it has been demonstrated to reduce the frequency of rash. This lead-in period is not required if the patient is already on a regimen of twice daily immediate-release formulation Adverse reactions were similar to those observed in adults. In pediatric patients the incidence of Grade 2 or higher drug-related rash was 1%Information on recommended dosing based on BSA, pharmacokinetics, adverse reactions, and clinical trial Postmarketing study
|
Labeling
|
|
P
|
|
|
Boehringer Ingelheim
|
|
FALSE'
|
Antiviral
|
11/30/2012
|
Invirase
|
saquinavir
|
Treatment of HIV infection in combination with ritonavir
|
The safety and activity of saquinavir have been evaluated in 68 pediatric patients 4 months -< 16 years treated with Invirase boosted with either ritonavir or with lopinavir/ritonavir in 2 clinical trials. Steady state saquinavir exposures observed in pediatric trials were substantially higher than historical data in adults where dose- and exposure-dependent QTc and PR prolongation were observed. Pediatric dose recommendations that are both reliably effective and below thresholds of concern with respect to QT and PR prolongation could not be determined. Information on clinical studies, and pharmacokinetics
|
Labeling
|
|
|
B,P
|
|
Hoffman- LaRoche
|
10/26/2010
|
FALSE'
|
Antiviral
|
12/14/2012
|
Fluarix Quadrivalent
|
Influenza Virus Vaccine
|
Include a quadrivalent influenza virus vaccine formulation (Fluarix® Quadrivalent)
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Vaccine
|
12/19/2012
|
Advair HFA
|
fluticasone/ salmeterol
|
Treatment of asthma
|
Safety and effectiveness in children < 12 years have not been established.Information on clinical trials, adverse reactions, and pharmacokinetics/ pharmacodynamics, Postmarketing study
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Antiasthmatic
|
12/21/2012
|
Altabax Ointment
|
retapamulin
|
Treatment of impetigo
|
Use of retapamulin is not indicated in pediatric patients < 9 monthsIn an open-label clinical study of topical treatment in pediatric patients 2 to 24 months, systemic exposure of retapamulin was higher compared with patients 2 to 17 years. A higher proportion of pediatric patients 2 to 9 months of age had measurable concentrations of retapamulin compared with patients 9 to 24 months of age. The highest levels were seen in patients 2 to 6 months of agePostmarketing study
|
Labeling
|
|
P
|
|
|
Stiefel Laboratories
|
|
FALSE'
|
Antibiotic, topical
|
01/09/2013
|
Skyla
|
levonorgestrel-releasing intrauterine system
|
Prevention of pregnancy for up to 3 years
|
Safety and efficacy have been established in women of reproductive ageEfficacy is expected to be the same for postpubertal females under the age of 18 years as for users 18 years and olderUse of this product before menarche is not indicatedNew drug
|
Labeling
|
|
P
|
|
|
Bayer
|
|
TRUE'
|
Contraceptive
|
01/23/2013
|
Exjade
|
deferasirox
|
Treatment of chronic iron overload in patients with non-transfusion dependent thalassemia
|
Approved for use in 10 years and older for NTDT Safety and effectiveness have not been established in pediatric patients less than 10 years Information on dosing, adverse reactions in adults and pediatric patients, and clinical trials New indication
|
Labeling; Labeling
|
|
P
|
|
|
Novalar Pharmaceuticals, Inc.
|
|
FALSE'
|
Iron chelator
|
01/25/2013
|
Prevnar 13
|
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
|
Active immunization for the prevention of invasive pneumococcal disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Wyeth
|
|
FALSE'
|
Preventive Vaccine
|
02/01/2013
|
Epiduo
|
adapalene and benzoyl peroxide
|
Treatment of acne vulgaris
|
Expanded age range down to 9 years; previously approved in pediatric patients 12 years and olderSafety and effectiveness in pediatric patients < 9 years have not been establishedAdverse reactions were similar to those observed in adultsInformation on clinical trialPostmarketing study
|
Labeling
|
|
P
|
|
|
Galderma
|
|
FALSE'
|
Antiacne, topical
|
02/01/2013
|
Prezista
|
darunavir
|
Treatment of HIV-1 infection
|
Revised labeling to include once daily dosing in treatment naïve and treatment experienced HIV-1 infected pediatric patients 3 to < 18 years and weighing at least 10 kg Postmarketing study
|
Labeling
|
|
P
|
|
|
Janssen
|
|
FALSE'
|
Antiviral
|
02/06/2013
|
Zylet
|
loteprednol etabonate and tobramycin
|
Treatment of blepharoconjunctivitis
|
Efficacy was not demonstrated in a study of pediatric patients 0-6 years
|
Labeling
|
B
|
|
|
|
Bausch and Lomb
|
12/28/2010
|
FALSE'
|
Antibiotic, topical
|
02/27/2013
|
Intelence
|
etravirine
|
Postmarketing study
|
Information on 48 week safetyThe safety profile for patients who completed 48 weeks of treatment was similar to the safety profile for patients who completed 24 weeks of treatmentPostmarketing study
|
Labeling
|
|
P
|
|
|
Janssen
|
|
TRUE'
|
Antiviral
|
03/15/2013
|
Recothrom
|
Thrombin, topical (Recombinant)
|
Aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Zymogenetics, Inc.
|
|
FALSE'
|
Topical thrombin
|
03/20/2013
|
Dotarem
|
gadoterate meglumine
|
Contrast agent for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity
|
Safety and efficacy have been established in pediatric patients from 2 to 17 yearsSafety and efficacy have not been established in pediatric patients < 2 yearsInformation on clinical trial, dosing, adverse reactionsNew Drug
|
Labeling
|
|
P
|
|
|
Guerbet
|
|
FALSE'
|
Medical imaging
|
03/21/2013
|
Phenylephrine Hydrochloride
|
phenylephrine hydrochloride
|
Dilation of the pupil
|
The 2.5% solution are approved for use in pediatric patients of all agesThe 10% solution is approved for patients 1 year and older and contraindicated in pediatric patients < 1 year of age due to the increased risk of systemic toxicityNew Drug
|
Labeling
|
|
P
|
|
|
Paragon BioTech, Inc.
|
|
TRUE'
|
Ophthalmologic
|
03/22/2013
|
Durezol
|
difluprednate
|
Treatment of post-operative inflammation following cataract surgery
|
Expanded the indication from adults to pediatric patientsDifluprednate compared to prednisolone acetate ophthalmic was evaluated in a 3-month, multicenter, double-masked trial in 79 pediatric patients 0 to 3 years for the treatment of inflammation following cataract surgeryA similar safety profile was observed in pediatric and adult patients
|
Labeling
|
B
|
|
|
|
Alcon
|
03/21/2013
|
FALSE'
|
Anti-inflammatory, topical
|
03/26/2013
|
Aciphex
|
rabeprazole
|
Gastroesophageal reflux
|
Expanded the indication to pediatric patients down to 1 year; previously approved in pediatric patients 12 years and older Studies do not support the use in pediatric patients < 1 year Use in neonates is strongly discouraged based on the risk of prolonged acid suppression and lack of demonstrated safety and effectiveness in neonates Adverse reactions were similar to those observed in adults and adolescents Information on clinical studies, dosing, population PK in neonates, and adverse reaction
|
Labeling
|
|
|
B,P
|
|
Eisai Medical Research
|
12/04/2012
|
FALSE'
|
Antiulcerative
|
03/28/2013
|
Quartette
|
levonorgestrel/ethinyl estradiol and ethinyl estradiol
|
Prevention of pregnancy
|
Safety and efficacy have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents less than 18 years and for users 18 years and older. Use before menarche is not indicated
|
Labeling
|
|
P
|
|
|
Teva
|
|
TRUE'
|
Contraceptive
|
03/28/2013
|
Karbinal ER
|
carbinoxamine maleate
|
Relief of seasonal and perennial allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis due to inhalant allergens and foods, mild uncomplicated allergic skin manifestations of urticaria and angioedema, dermatographism, as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled, and amelioration of the severity of allergic reactions to blood or plasma
|
Approved for use in 2-17 years Efficacy and safety is based on demonstration of bioequivalence to the immediate release product Deaths have been reported in children younger than 2 years who were taking carbinoxamine containing drug products. Therefore, Karbinal ER is contraindicated in children younger than 2 years of age and in nursing mothers. Carbinoxamine may diminish mental alertness or produce sedation in children Paradoxical reactions with excitation are more likely in younger children Karbinal ER must be measured with an accurate milliliter measuring device Information on safety, dosing, and adverse reactions •New dosage form
|
Labeling
|
|
P
|
|
|
Tris Pharma, Inc.
|
|
TRUE'
|
Antihistamine
|
03/29/2013
|
Salonpas Pain Relief
|
methyl salicylate 10% and l-menthol 3%
|
Temporary relief of mild to moderate aches and pains of muscles and joints associated with arthritis, simple backache, strains, bruises and sprains
|
Children under 18 years of age: do not use; this product has not been shown to work in children Postmarketing study
|
|
|
P
|
|
|
Hisamitsu Pharmaceutical Co., Inc.
|
|
FALSE'
|
Analgesic, topical
|
04/11/2013
|
Doryx
|
doxycycline hyclate
|
Uncomplicated urogenital Chlamydia trachomatis infection
|
New 200-mg strength tablet New alternative dosage regimen for adults and children at least 8 years and weighing 45 kg based on studies in adults New dosage form, new dosage regimen
|
Labeling
|
|
P
|
|
|
Mayne Pharma International
|
|
FALSE'
|
Antibiotic
|
04/24/2013
|
Prezista
|
darunavir
|
Treatment of HIV-1 infection
|
Revised labeling to include pharmacokinetic, safety, tolerability, and virologic response data from a 48 week study for HIV-1 treatment experienced pediatric patients 3 to < 6 years Additional information on adverse reactions Postmarketing study
|
Labeling
|
|
P
|
|
|
Jannsen
|
|
FALSE'
|
Antiviral
|
04/26/2013
|
Vyvanse Capsules
|
lisdexamfetamine
|
Maintenance treatment of ADHD
|
Approved for the maintenance treatment of ADHD in pediatric patients 6-17 years Information on one short term efficacy trial and one maintenance trial in pediatric patients 6-17 years New indication
|
Labeling
|
|
P
|
|
|
Shire
|
|
FALSE'
|
CNS Stimulant
|
04/30/2013
|
Seroquel and Seroquel XR
|
quetiapine
|
Bipolar depression
|
Efficacy was not established in an 8-week placebo-controlled monotherapy trial of Seroquel XR in children and adolescents 10-17 years with bipolar depression.In the same study patients treated with Seroquel XR exhibited metabolic changes, weight gain, and increases in blood pressure and heart rate. The most commonly observed adverse reactions were dizziness 7%, diarrhea 5%, fatigue 5% and nausea 5% Information on adverse reactions, clinical tria Postmarketing study
|
Labeling
|
|
P
|
|
|
AstraZeneca
|
|
FALSE'
|
Antipsychotic
|
05/02/2013
|
Sustiva
|
efavirenz
|
Treatment of HIV-1 infection
|
Labeling updated with dosing recommendations for pediatric patients 3 months - 3 years and weighing at least 3.5 kg Use in pediatric patients < 3 months OR less than 3.5 kg body weight is not recommended because the safety, pharmacokinetics, and antiviral activity have not been evaluated and there is a risk of developing HIV resistance if efavirenz is underdosed. Information on population PK, safety, virologic, and immunologic response from 3 open-label clinical trials in patients 3 months - 21 years.Postmarketing study
|
Labeling
|
|
|
B,P
|
|
Bristol-Myers Squibb
|
01/29/2013
|
FALSE'
|
Antiviral
|
05/17/2013
|
Ixiaro
|
Japanese Encephalitis Vaccine, Inactivated, Adsorbed
|
Prevention of disease caused by Japanese encephalitis virus
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Intercell Biomedical
|
|
FALSE'
|
Preventive Vaccine
|
05/30/2013
|
Kepivance
|
palifermin
|
Acute leukemias undergoing myeloablative therapy and allogeneic hematopoietic stem cell transplant
|
Use in pediatric patients ages 1 - 16 years is supported by evidence from adequate and well-controlled studies in adults and a phase 1 study that included 27 pediatric patients with acute leukemia undergoing hematopoietic stem cell transplant Postmarketing study
|
Labeling
|
|
P
|
|
|
Quintiles, Inc.
|
|
FALSE'
|
Immunologic agent
|
05/31/2013
|
Bloxiverz
|
neostigmine methylsulfate
|
Reversal of the effects of non-depolarizing neuromuscular-blocking agents after surgery
|
Approved for use in pediatric patients of all ages The evidence for efficacy of neostigmine is derived from the published literature Recovery of neuromuscular activity occurs more rapidly with smaller doses of cholinesterase inhibitors in infants and children than in adults. However, infants and small children may be at greater risk of complications from incomplete reversal of neuromuscular blockade due to decreased respiratory reserve. The risks associated with incomplete reversal outweigh any risk from giving higher doses of neostigmine Since the blood pressure in pediatric patients, particularly infants and neonates is sensitive to changes in heart rate, the effects of an anticholinergic agent (e.g., atropine) should be observed prior to administration of neostigmine to lessen the probability of bradycardia and hypotension Information on dose, and pk New drug
|
Labeling
|
|
P
|
|
|
Eclat Pharmaceuticals, LLC
|
|
FALSE'
|
Neuromuscular blockade reversal
|
06/07/2013
|
Fluzone Quadrivalent
|
Influenza Virus Vaccine
|
Active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
|
See Package Insert for new information on biologics
|
|
|
P
|
|
|
Sanofi Pasteur
|
|
FALSE'
|
Preventive Vaccine
|
06/17/2013
|
Precedex
|
dexmedetomidine hydrochloride
|
Loading and maintenance infusion for sedation in intubated and mechanically ventilated pediatric patients
|
Safety and efficacy have not been established for procedural or ICU sedation in pediatric patients One assessor-blinded trial in pediatric patients and two open label studies in neonates were conducted to assess efficacy for ICU sedation. These studies did not meet their primary efficacy endpoints and the safety data submitted were insufficient to fully characterize the safety profile of dexmedetomidine for this patient population Use for procedural sedation in pediatric patients has not been evaluated
|
Labeling
|
B
|
|
|
|
Hospira
|
03/12/2013
|
FALSE'
|
Sedative
|
06/21/2013
|
Mycamine
|
micafungin sodium
|
Treatment of patients with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses; treatment of patients with esophageal candidiasis; prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation
|
Safety and effectiveness in pediatric patients 4 months and older have been demonstrated based on the evidence from adequate and well-controlled studies in adult and pediatric patients and additional pediatric pharmacokinetic and safety dataSafety and effectiveness in pediatric patients < 4 months have not been establishedIn all pediatric studies with Mycamine, 439/479 (92%) patients experienced at least one treatment-emergent adverse reaction. Gastrointestinal symptoms including vomiting, diarrhea, nausea, abdominal pain, and abdominal distension occurred in 285 pediatric patients (60%)Information on population PK, dosing, adverse reactions, and clinical trials Postmarketing study
|
Labeling
|
|
|
B,P
|
|
Astellas
|
|
|
Antiviral
|
07/26/2013
|
Symbyax
|
olanzapine and fluoxetine hydrochloride
|
Treatment of depressive episodes associated with bipolar I disorder
|
Expanded the indication from adults to pediatric patient 10-17 years Safety and efficacy for treatment resistant depression in patients < 18 years have not been established Symbyax is not approved for any indication in patients < 10 years In a placebo-controlled clinical trial in patients 10 to 17 years, somnolence-related adverse events were commonly reported with drug treatment occurring in 23.5% of drug-treated patients compared with 2.4% of placebo-treated patients The types of adverse reactions observed with olanzapine and fluoxetine hydrochloride in children and adolescents were similar to adult but the magnitude and frequency of some changes were greater in children and adolescents than adults. These included increases in lipids, hepatic enzymes, and prolactin, and increases in the QT interval. The frequency of weight gain greater than or equal to 7%, and the magnitude and frequency of increases in lipids, hepatic analytes, and prolactin in children and adolescents treated with olanzapine and fluoxetine hydrochloride were similar to those observed in adolescents treated with olanzapine monotherapy Overall, 14.1% of the 170 patients in the olanzapine and fluoxetine hydrochloride group discontinued due to adverse reactions compared with 5.9% of the 85 patients for placebo. Adverse reactions leading to discontinuation associated with the use of olanzapine and fluoxetine hydrochloride were weight increased (2.9%), suicidal ideation (1.8%), bipolar disorder (1.2%), and somnolence (1.2%) versus placebo patients which had 0% incidence of weight increased, bipolar disorder, and somnolence, and a 1.2% incidence of suicidal ideation Information on dosing, clinical trial, and adverse reactionsLabeling
|
|
P
|
|
|
|
Lilly
|
|
Antidepressant
|
|
08/01/2013
|
MENVEO
|
Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
|
Active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Novartis
|
|
FALSE'
|
Preventive Vaccine
|
08/12/2013
|
Tivicay
|
dolutegravir
|
Treatment of HIV-1 infection
|
Indicated in combination with other antiretroviral agents in adults and children aged 12 years and older and weighing at least 40 kg Not recommended in pediatric patients <12 years or weighing < 40 kg Safety and efficacy have not been established in pediatric patients who are integrase strand transfer ibitor (INSTI)-experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir) The safety, virologic, and unologic were evaluated in 23 treatment-experienced, INSTI-naïve, HIV-1 infected patients aged 12 - < 18 years in an open-label, multicenter, dose-finding clinical trial Adverse reactions were similar to those observed in adults Information on dosing, clinical trial, and PK New drug
|
Labeling
|
|
P
|
|
|
ViiV Healthcare
|
|
FALSE
|
Antiviral
|
08/16/2013
|
FluLaval
|
Influenza Virus Vaccine
|
Active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline Biologicals
|
|
|
Preventive Vaccine
|
08/16/2013
|
FluLaval Quadrivalent
|
Influenza Virus Vaccine
|
Active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline Biologicals
|
|
|
Preventive Vaccine
|
08/21/2013
|
Lysteda
|
tranexamic acid
|
Treatment of cyclic heavy menstrual bleeding
|
Indicated for women of reproductive age. It is not intended for use in premenarcheal girls Information on PK studyPostmarketing study
|
|
P
|
|
|
Ferring
|
|
FALSE
|
Antifibrinolytic
|
08/30/2013
|
Astepro Nasal Spray
|
azelastine
|
Treatment of perennial and seasonal allergic rhinitis
|
Expanded the indication to pediatric patients down to 6 years; previously approved in pediatric patients 12 years and older Safety and effectiveness in pediatric patients < 6 years have not been established Information on dosing, clinical trial, and adverse reactions Postmarketing study
|
Labeling
|
|
P
|
|
|
Meda
|
|
FALSE'
|
Anti-inflammatory, topical
|
10/15/2013
|
Novoeight
|
Antihemophilic Factor (Recombinant)
|
For adults, adolescents, and children with hemophilia A for (1) the control and prevention of bleeding episodes, (2) perioperative management, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Novo Nordisk
|
|
FALSE'
|
|
10/18/2013
|
Asacol
|
mesalamine***
|
Treatment of mildly to moderately active ulcerative colitis
|
Safety and effectiveness in pediatric patients 5 - 17 years have been established over a 6-week period. Use in this age group is supported by evidence from studies in adults and 1 study in pediatric patientsSafety and effectiveness in pediatric patients below 5 years have not been establishedSafety and effectiveness for the maintenance of remission of ulcerative colitis in pediatric patients have not been establishedAdverse reactions in the pediatric population were similar to those reported in adultsInformation on dose, adverse reactions, PK and clinical trialsPostmarketing study
|
|
|
|
B,P
|
|
Warner Chilcott
|
|
FALSE
|
Anti-inflammatory
|
10/18/2013
|
Asacol HD
|
mesalamine
|
Postmarketing study using Asacol
|
Safety and effectiveness of Asacol HD in pediatric patients have not been established Since studies were performed in Asacol rather than Asocol HD, information added to labeling referring reader to prescribing information for other approved mesalamine products for the safety and effectiveness of these products in pediatric patients
|
Labeling
|
|
|
P
|
|
Warner Chilcott
|
|
TRUE'
|
Anti-inflammatory
|
10/24/2013
|
Ecoza
|
econazole nitrate
|
Treatment of interdigital tinea pedis
|
Approved for use in 12 years and older Safety findings for patients 12 - 17 years were similar to those in adults Information on clinical trials and PKNew dosage form
|
Labeling
|
|
P
|
|
|
AmDerma Pharmaceuticals, LLC
|
|
FALSE'
|
Antifungal, topical
|
10/26/2013
|
Sabril
|
vigabatrin
|
Refractory complex partial seizures (rCPS)
|
Approved as adjunctive therapy for pediatric patients 10 years and older with rCPS for whom the potential benefits outweigh the risk of vision loss. Sabril is not a first line agent for rCPS Safety and effectiveness for pediatric patients less than 10 years with refractory rCPS have not been established Pooled data from 3 controlled trials in pediatric patients demonstrated that 6% (10/165) of Sabril patients experienced somnolence compared to 5% (5/104) of placebo patients. In those same studies, 10% (17/165) of Sabril patients experienced fatigue compared to 7% (7/104) of placebo patients; 47% (77/163) of Sabril patients versus 19% (19/102) of placebo patients gained greater than or equal to 7% of baseline body weight Adverse reactions (ARs) in the pediatric population were similar to those reported in adults. Overall, ARs in pediatric patients 10-16 years included increased weight, upper respiratory tract infection, tremor, fatigue, aggression and diplopia Information on weight based dosing, dosing in renal impairment, safety information and clinical trials
|
Labeling
|
|
|
B,P
|
|
Lundbeck LLC
|
10/03/2013
|
FALSE'
|
Anticonvulsant
|
11/22/2013
|
Nitropress
|
sodium nitroprusside
|
Immediate reduction of blood pressure in hypertensive crisis
|
*Efficacy in the pediatric population was established based on adult trials and supported by a dose-ranging trial and an open label trial that achieved adequate mean arterial pressure control in pediatric patients. *No novel safety issues were found in these two studies. *Information on dosing, PK parameters and clinical trials. *Off-patent Written Request.
|
|
B
|
|
|
|
Hospira
|
|
FALSE
|
Antihypertensive
|
11/25/2013
|
Noxafil
|
posaconazole
|
Prophylaxis of invasive Aspergillus and Candida infections in high risk patients
|
Safety and effectiveness have been established in pediatric patients 13 - 17 years. Use is supported by evidence from adequate and well-controlled studies in adults. PK and safety in pediatric patients 13 - 17 years were also assessed and are similar to adults.Safety and effectiveness in pediatric patients less than 13 years have not been establishedInformation on dosing, PK, and clinical trials
|
Labeling
|
|
|
B,P
|
|
Merck Sharp & Dohme Corp.
|
|
FALSE'
|
Antifungal
|
12/10/2013
|
Xeloda
|
capecitabine
|
Newly diagnosed brainstem gliomas and high grade gliomas
|
The safety and effectiveness in pediatric patients have not been established No clinical benefit was demonstrated in 2 single arm trials in pediatric patientsThe adverse reaction (AR) profile was consistent with the known AR profile in adults, with the exception of laboratory abnormalities which occurred more commonly in pediatric patientsInformation on dosing, adverse reactions, and clinical trials
|
Labeling
|
B
|
|
|
|
Hoffman- LaRoche
|
|
FALSE'
|
Antineoplastic
|
12/20/2013
|
Isentress
|
raltegravir
|
HIV-1 infection
|
Packet for oral suspension: Approved for use in infants 4 weeks and older, weighing at least 3 kg to < 20 kg. Chewable tablet previously approved down to 2 yearsSafety and dosing information have not been established in infants less than 4 weeks Adverse reactions similar to those observed in adultsInformation on dosing,clinical trial and PK parametersInformation on preparation of a suspensionNew dosage form
|
Labeling
|
|
P
|
|
|
Merck Sharp & Dohme Corp.
|
|
FALSE'
|
Antiviral
|
01/17/2014
|
Aleve PM
|
naproxen sodium 220 mg and diphenhydramine hydrochloride 25 mg
|
Relief of occasional sleeplessness when associated with minor aches and pains and helps fall asleep and stay asleep
|
Approved for use in adults and children 12 years and older Not approved for use in children less than 12 yearsNew drug
|
Labeling
|
|
P
|
|
|
Bayer HealthCare, LLC – Consumer Care
|
|
FALSE'
|
anti-inflammatory+sleep aid
|
01/22/2014
|
Xerese
|
acyclovir/ hydrocortisone
|
Treatment of recurrent herpes labialis
|
Expanded indication to include 6 years to less than 12 years; previously approved for use in 12 years and older Safety and effectiveness in pediatric patients less than 6 years of age have not been established Adverse reactions similar to those observed in adultsInformation on dose, and clinical trial
|
Labeling
|
|
P
|
|
|
Valeant International Bermuda
|
|
FALSE'
|
Antiviral, topical
|
03/06/2014
|
Revatio
|
sildenafil
|
Treatment of pulmonary arterial hypertension (PAH)
|
Labeling updated to include information on results of an open-label pediatric safety extension studyDuring the study, there were 42 deaths with 37 of these deaths reported prior to a decision to titrate patients to a lower dosage because of a finding of increased mortality. An increase in mortality was observed with increasing doses Causes of death in the extension study were typical of patients with PAH
|
Labeling
|
B
|
|
|
|
Pfizer
|
02/09/2012
|
FALSE'
|
Peripheral vasodilator
|
03/07/2014
|
Pancreaze
|
pancrelipase
|
Postmarketing study
|
New dosage strength of 2,600 USP lipase units to allow for dosing in infants up to 12 monthsPostmarketing studyNew dosage form
|
Labeling
|
|
P
|
|
|
Janssen
|
|
FALSE'
|
Pancreatic enzyme
|
03/20/2014
|
Baraclude
|
entecavir
|
Treatment of chronic hepatitis B virus (HBV) infection
|
Approved for use in pediatric patients 2 years and older Safety and effectiveness have not been established in pediatric patients less than 2 years. Use in this age group has not been evaluated because treatment of HBV in this age group is rarely required There are limited data available on the use of Baraclude in lamivudine-experienced pediatric patients Adverse reactions in clinical trials were similar to those observed in adults Information on dosing in pediatric patients 2 years and weighing at least 10 kg, adverse reactions, PK parameters and clinical trials New dosage form
|
Labeling
|
|
|
B,P
|
|
Bristol-Myers Squibb
|
|
FALSE'
|
Antiviral
|
03/21/2014
|
Xolair
|
omalizumab
|
Chronic Idiopathic Urticaria (CIU)
|
Approved for the treatment of CIU in adults and pediatric patients 12 years and older who remain symptomatic despite H1 antihistamine treatment Clinical studies with Xolair have not been conducted in CIU patients less than 12 years. Considering the risk of anaphylaxis and malignancy seen in Xolair-treated patients 12 years and older, the use of Xolair in patients less than 12 years is not recommended Dosing in CIU is not based on serum IgE level or body weight Adverse reactions in adolescents and adults were similar and include miscellaneous infections, arthralgias, headache, nausea, and cough Information on adverse reactions, dosing, and clinical trials in adults and pediatric patients 12 years and older
|
Labeling
|
|
P
|
|
|
Genentech
|
|
FALSE'
|
Antiasthmatic; antiallergy
|
03/28/2014
|
Topamax
|
topiramate
|
Prophylaxis of migraine headache
|
Approved for use in pediatric patients 12 years and older Safety and effectiveness in pediatric patients less than12 years have not been established for the prophylaxis treatment of migraine headache In the adolescent migraine trials (12 to 17 years), the most commonly observed adverse reactions were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain The most common cognitive adverse reaction in pooled double-blind studies in adolescent patients 12 to 17 years was difficulty with concentration/attention Markedly abnormally low serum bicarbonate values indicative of metabolic acidosis were reported in topiramate-treated adolescent migraine patients In topiramate-treated patients 12 to 17 years compared to placebo-treated patients, abnormally increased results were more frequent for creatinine, BUN, uric acid, chloride, ammonia, total protein, and platelets. Abnormally decreased results were observed with topiramate vs placebo treatment for phosphorus and bicarbonate Notable changes (increases and decreases) from baseline in systolic blood pressure, diastolic blood pressure, and pulse were observed more commonly in adolescents treated with topiramate compared to adolescents treated with placebo Information on dosing, adverse reactions, laboratory abnormalities, and clinical trials Postmarketing study
|
Labeling
|
|
P
|
|
|
Janssen
|
|
FALSE'
|
Antimigraine
|
04/01/2014
|
ORALAIR
|
Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract
|
Treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Stallergenes
|
|
FALSE
|
Antiallergy
|
04/11/2014
|
GRASTEK
|
Timothy Grass Pollen Allergen Extract
|
Treatment of grass pollen-induced allergic rhinitis or conjunctivitis
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Merck Sharp & Dohme Corp.
|
|
FALSE'
|
Immunologic agent
|
04/23/2014
|
Kuvan
|
sapropterin dihydrochloride
|
Treatment to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU)
|
Expanded indication to include 1 month to 4 years; previously approved for use in 4 years and older Safety and effectiveness have not been established in neonates Adversereactions observed in pediatric patients 1 month – 6 years were similar to adults except for an increased incidence of low Phe levels. 25% (16/65) experienced low Phe for age Information on adding crushed tablet or powder for oral solution to small amounts of soft food such as apple sauce Information on dosing, adverse reactions, PK parameters, and clinical trials
|
|
B
|
|
|
|
BioMarin Pharmaceutical Inc.
|
03/13/2014
|
FALSE
|
|
04/25/2014
|
Asmanex HFA
|
mometasone furoate
|
Maintenance treatment of asthma as prophylactic therapy
|
Approved for use in adults and pediatric patients 12 years and older Safety and efficacy hav not been established in children less than 12 years The growth of pediatric patients receiving orally inhaled corticosteroids should be monitored routinely To minimize the systemic effects of orally inhaled corticosteroids each patient should be titrated to his/her lowest effective dose Information on dosing, adverse reactions, and clinical trials New dosage form
|
Labeling
|
|
P
|
|
|
Merck Sharp & Dohme Corp.
|
|
FALSE'
|
Antiasthmatic
|
04/28/2014
|
Delzicol
|
mesalamine
|
Treatment of mildly to-moderately active ulcerative colitis
|
Approved for use in pediatric patients 12 years and older based on clinical trials conducted with mesalamine 400 mg delayed release tablets which is approved in 5-17 yearsDelzicol is bioequivalent to the mesalamine delayed-release tablets There is no age appropriate Delzicol formulation available for patients less than 12 years Safety and effectiveness of Delzicol in the maintenance of remission of ulcerative colitis in pediatric patients have not been established Information on dosingNew dosage form
|
Labeling
|
|
P
|
|
|
Warner Chilcott
|
|
FALSE'
|
Anti-Inflammatory
|
05/27/2014
|
Aloxi
|
palonosetron hydrochloride
|
Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) and postoperative nausea and vomiting (PONV)
|
Chemotherapy-Induced Nausea and Vomiting Approved for prevention of acute CINV in 1 month - < 17 yearsSafety and effectiveness in neonates less than 1 month of age have not been establishedPediatric patients require a higher palonosetron dose than adults (20 mcg/kg with max of 1.5 mg x 1 vs 0.25 mg x 1 Adverse reactions were similar to those observed in adults Information on dosing, PK parameters, clinical trial, adverse reactions Postoperative Nausea and Vomiting Studies Safety and efficacy have not been established in pediatric patients for PONV Adverse reactions were similar to those observed in adultsInformation on dosing, clinical trials
|
Labeling
|
|
|
B,P
|
|
Helsinn Healthcare SA
|
|
FALSE'
|
Antiemetic
|
06/02/2014
|
Reyataz
|
atazanavir
|
Treatment of HIV - 1 infection
|
Reyataz oral powder approved for use in pediatric patients at least 3 months and between 10 kg to less than 25 kg; capsule previously approved in 6 years and olderNot recommended in pediatric patients less than 3 months because of the risk of kernicterusReyataz oral powder contains phenylalanine which can be harmful to patients with phenylketonuria Adverse reactions were similar to those observed in adultsOral powder must be mixed with food or beverage for administration and ritonavir must be given immediately afterwards Information on mixing oral powder with food such as appleasauce or yogurt or milk, water or infant formula Information on dosing in patients at least 3 months and weighing between 10 to less than 25kg, adverse reactions, laboratory abnormalities, PK parameters, and clinical trialsNew dosage form
|
Labeling
|
|
|
B,P
|
|
Bristol-Myers Squibb
|
|
FALSE'
|
Antiviral
|
06/09/2014
|
Abilify
|
aripiprazole
|
Maintenance treatment of irritability associated with autistic disorder
|
Efficacy for the maintenance treatment of irritability associated with autistic disorder was not established in a 12 week clinical trial in 85 pediatric patients 6-17 years Information on clinical trialPostmarketing study
|
Labeling
|
|
P
|
|
|
Otsuka
|
|
FALSE'
|
Antipsychotic
|
06/13/2014
|
Jetrea
|
ocriplasmin
|
Adjunct to vitrectomy
|
*The use of Jetrea in pediatric patients is not recommended. *A single center, placebo controlled, clinical study to investigate a single intravitreal injection of ocriplasmin in pediatric patients as an adjunct to vitrectomy was conducted in 24 eyes of 22 patients. * There were no statistical or clinical differences between groups for the induction of total macular PVD, any of the secondary endpoints or adverse events. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
ThromboGenics, Inc.
|
|
FALSE
|
|
07/03/2014
|
Namenda XR
|
memantine hydrochloride
|
Autism spectrum disorders
|
The safety and effectiveness of memantine have not been established in pediatric patients Memantine failed to demonstrate efficacy in two 12-week controlled clinical studies of 578 pediatric patients aged 6-12 years with autism spectrum disorders Adverse reactions were similar to those observed in adultsInformation on dosing, adverse reactions, clinical trials
|
Labeling
|
B
|
|
|
|
Forest Research Institute, Inc.
|
06/16/2014
|
FALSE'
|
|
07/18/2014
|
Atropine Sulfate
|
atropine sulfate
|
Mydriasis, cycloplegia, and penalization of the healthy eye in the treatment of amblyopia in children 3 months and older
|
*Approved for use in adults and pediatric patients 3 months and older. * Due to the potential for systemic absorption of atropine sulfate ophthalmic solution, use in children under the age of 3 months is not recommended and the use in children under 3 years of age should be limited to no more than one drop per eye per day. *New indication
|
|
|
P
|
|
|
Akorn
|
|
FALSE
|
Ophthalmologic
|
08/01/2014
|
Keppra XR
|
levetiracetam
|
Adjunctive therapy in the treatment of partial onset seizures
|
Safety and effectiveness in pediatric patients 12 years and older have been established based on PK data in adults and adolescents using Keppra XR and efficacy and safety data in pediatric studies using immediate-release Keppra Safety and effectiveness of in patients below the age of 12 years have not been established Information on PK parameters and PK study Postmarketing study
|
Labeling
|
|
P
|
|
|
UCB
|
|
FALSE'
|
Anticonvulsant
|
08/20/2014
|
Arnuity Ellipta
|
fluticasone furoate
|
Maintenance treatment of asthma as prophylactic therapy
|
Approved for use in adults and pediatric patients 12 years and older Safety and efficacy in pediatric patients younger than 12 years have not been established Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to children and adolescents. The growth of children and adolescents receiving orally inhaled corticosteroids, including Arnuity Ellipta, should be monitored routinely. The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks associated with alternative therapies Information on safety, adverse events and clinical trials New dosage form
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE'
|
Antiasthmatic
|
08/29/2014
|
Taclonex
|
calcipotriene/ betamethasone dipropionate
|
Plaque psoriasis of the scalp
|
Expanded the indication from adults to pediatric patients 12 – 17 years Safety and effectiveness have not been established in pediatric patients less than 12 years In a trial to evaluate the effect on HPA axis suppression in pediatric patients 12 – 17 years, adrenal suppression was identified in 1 of 30 patients (3.3%) after 4 weeks of treatment Rare systemic toxicities such as Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids Local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients Information on dose and maximum weekly dose, adverse reactions, and clinical trials Postmarketing study
|
Labeling
|
|
P
|
|
|
LEO Pharma
|
|
FALSE'
|
Anti-inflammatory, topical
|
09/04/2014
|
Latisse
|
bimatoprost
|
Treatment of hypotrichosis
|
Use was evaluated in a 16 week double-masked, randomized, vehicle controlled study in pediatric patients with several different conditions (post-chemotherapy, alopecia areata, and adolescents with hypotrichosis and no associated medical condition No new safety issues were observed Postmarketing study
|
Labeling
|
|
P
|
|
|
Allergan
|
|
FALSE'
|
Antiglaucome
|
09/10/2014
|
Emsam
|
selegiline
|
Treatment of major depressive disorder
|
Multi-center, randomized, double-blind, placebo-controlled, flexible-dose trial in 308 adolescents 12 – 17 years failed to demonstrate efficacy Emsam should not be used in patients less than 18 years. Use in patients less than 12 years is contraindicated because of the potential for a hypertensive crisis, which may be increased compared to adolescents and adults based on limited PK data suggesting higher exposure even at the lowest dose Adverse events were similar to those observed in adults Postmarketing study
|
Labeling
|
|
P
|
|
|
Somerset Pharmaceuticals, Inc.
|
|
FALSE'
|
Antidepressant
|
09/12/2014
|
RIXUBIS
|
Coagulation Factor IX (Recombinant)
|
Control and prevention of bleeding episodes, perioperative management, and routine prophylaxis
|
See Package Insert for new information on biologics
|
|
|
P
|
|
|
Baxter
|
|
FALSE'
|
Coagulant
|
10/10/2014
|
Naftin
|
naftifine hydrochloride
|
Interdigital tinea pedis
|
Use in 12 – 18 years is supported by evidence from adequate and well controlled studies in adults with additional safety and PK data from an open label trial in 22 adolescents 12 years and older exposed to Naftin Gel at a dose of approximately 4 g/day Safety and effectiveness in pediatric patients less than12 years have not been established Adverse reactions were similar to those observed in adults Postmarketing study
|
Labeling
|
|
P
|
|
|
Merz Pharmaceuticals
|
|
FALSE'
|
Antifungal, topical
|
10/16/2014
|
Cymbalta
|
duloxetine hydrochloride
|
Generalized Anxiety Disorder
|
*The safety and efficacy for GAD in 7 to 17 years of age was demonstrated in one 10-week, placebo-controlled trial (n=272) *Safety and effectiveness in pediatric patients less than 7 years have not been established. *The most frequently observed ARs in the pediatric trials included nausea, headache, weight reduction, and abdominal pain *Weight and height should be regularly monitored in children and adolescents treated with duloxetine *The average steady-state duloxetine concentration was about 30% lower in children and adolescents relative to adults
|
Labeling
|
|
P
|
|
|
Lilly
|
|
|
Antidepressant
|
10/23/2014
|
Zetonna
|
ciclesonide
|
Postmarketing study
|
*Efficacy and safety were established in pediatric patients aged 6-11 years with perennial allergic rhinitis in one 12 week, randomized, double blind, parallel placebo-controlled, 2 dose clinical trial with 846 pediatric patients. *Long-term nasal and ocular safety were evaluated in one 26-week, postmarketing, randomized, open-label, active-controlled trial in a total of 737 patients 12-74 years of age. Epistaxis was observed in 6% of patients. *Efficacy was not established in pediatric patients aged 6-11 years with seasonal allergic rhinitis in one 2 week, randomized, double blind, parallel placebo-controlled, 2 dose clinical trial (n= 847) *The effect on the HPA axis was evaluated in one 6 week study in children aged 6-11 years with perennial allergic rhinitis and results were consistent with the fundings observed in the adolescents *The safety in 6 to 11 year old children was similar to patients 12 years and older and no new safety concerns were identified. *Studies in children under 6 years of age have not been conducted
|
Labeling
|
|
P
|
|
|
Takeda
|
|
|
Antiasthmatic; antiallergy
|
10/29/2014
|
Trumenba
|
Meningococcal Group B Vaccine
|
Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B
|
See Package Insert for new information on biologics
|
|
|
P
|
|
|
Wyeth
|
|
FALSE'
|
Vaccine
|
10/30/2014
|
Keppra
|
levetiracetam
|
Partial onset seizures in patients 1 month and older; Primary generalized tonic-clonic seizures in patients 6 years and older; Myoclonic seizures in patients with juvenile myoclonic epilepsy 12 years and older
|
*Safety and efficacy established for adjunctive treatment of Partial onset seizures (POS, 1 mo to 16 years), Primary generalized tonic clonic seizures (PGTC, 6- 16 years), Myoclonic seizures (12-16 years) *Efficacy for adjunctive treatment of POS established in two multicenter, randomized double-blind, placebo-controlled trials: one trial enrolled 198 patients aged 4-16 years; the other enrolled 116 patients aged 1 month to less than 4 years with partial seizures, uncontrolled by standard epileptic drugs. *Efficacy for adjunctive treatment of PGTC established in one multicenter, randomized double-blind, placebo-controlled trial in 164 patients aged 6 years and older with idiopathic generalized epilepsy experiencing primary generalized tonic-clonic seizures. *Efficacy for adjunctive treatment of myoclonic seizures established in one multicenter, randomized double-blind, placebo-controlled trial in 120 patients aged 12 years and older with juvenile myoclonic epilepsy experiencing myoclonic seizures. *PK studies in pediatric patients established weight-based dosing. *In a 3-month, randomized, double-blind, placebo-controlled study of levetiracetim in 98 patients, aged 4-16 years with partial seizures that were inadequately controlled on prior therapy, there were noeurocognitive or behavioral differences between levetiracetim and placebo. *Common adverse reactions in pediatric patients include fatigue, aggression, nasal congestion, decreased appetite, irritability, decrease in WBC and neutrophil counts, increase in diastolic blood pressure *Age-specific toxicity was studied in juvenile rates and dogs at doses of up to 1800 mg/kg/day and did not indicate a potential for age-specific toxicity
|
Labeling
|
|
P
|
|
|
UCB
|
|
|
Anticonvulsant
|
10/31/2014
|
Lexapro
|
escitalopram oxalate
|
Major depressive disorder
|
*An open-label safety study in 118 children aged 7-11 years who had MDD, did not identify any new safety concerns. Efficacy was not established in this study
|
Labeling
|
|
P
|
|
|
Forest
|
|
|
Antidepressant
|
11/19/2014
|
Intuniv
|
guanfacine
|
Attention Deficit Hyperactivity Disorder (ADHD)
|
*Two new pediatric studies were conducted. *A 15-week study conducted in 314 adolescents aged 13-17 years *A 12-week (for children aged 6-12) or 15-week (for adolescents aged 13-17)study conducted in 337 pediatric patients aged 6-17 years inclusive. *New dosing regimen (weight-based dosing up to 7 mg/day in adolescents) *Effectiveness for longer than 15 weeks has not been evaluated in controlled trials in pediatrics * Safety and efficacy in pediatric patients less than 6 years have not been established
|
|
|
|
B, P
|
|
Shire
|
10/17/2014
|
|
Non-stimulant ADHD treatment
|
11/20/2014
|
Kapvay Extended Release Tablets
|
clonidine
|
Attention Deficit Hyperactivity Disorder (ADHD)
|
*One additional study was conducted. *A 40-week, dose optimization, randomized withdrawal study of 135 pediatric patients 6 to 17 years. *Blood pressure (BP): Mean increases in both systolic and diastolic BP (SBP/DBP) Hg were seen in drug treated patients. *Heart rate (HR): Mean decreases in HR were noted in drug treated patients
|
Labeling
|
|
P
|
|
|
Concordia Pharmaceuticals, Inc.
|
|
|
Non-stimulant ADHD treatment
|
11/25/2014
|
Priftin
|
rifapentine
|
Treatment of latent tuberculosis infection (LTBI) caused by Mycobacterium tuberculosis in combination with isoniazid (INH)
|
*At the time of approval, the safety and effectiveness of PRIFTIN in combination with isoniazid (INH) once-weekly regimen for the treatment of LTBI was established *A study of 742 pediatric patients (2-17 years of age) compared the effectiveness of 12 weekly doses of PRIFTIN in combination with INH (3RPT/INH arm) administered by directly observed therapy to 9 months of self-administered daily INH (9INH arm) *The safety profile in children in clinical studies was similar to that observed in adults *Weight based dosage recommendations for treatment of LTBI
|
Labeling
|
|
P
|
|
|
Sanofi Aventis
|
|
|
|
12/10/2014
|
Gardasil 9
|
Human Papillomavirus 9-valent Vaccine, Recombinant*
|
Indicated in girls and women 9 through 26 years of age for prevention of the following diseases: Cervical, vulvar, vaginal, and anal cancer caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58, Genital warts (condyloma acuminata) caused by HPV types 6 and 11, and the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS). Cervical intraepithelial neoplasia (CIN) grade 1. Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3. Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3. Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. Human Papillomavirus 9-valent Vaccine, Recombinant is indicated in boys 9 through 15 years of age for the prevention of the following diseases: •Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58. Genital warts (condyloma acuminata) caused by HPV types 6 and 11. nd the following Aprecancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58: •Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Merck Sharp & Dohme Corp.
|
|
|
Preventative Vaccine
|
12/17/2014
|
QNASL
|
beclomethasone dipropionate
|
Treatment of the nasal symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis
|
*Indication extended to pediatric patients aged 4 years and older. *The efficacy and safety of QNASL Nasal Aerosol have been established in 2 clinical trials of 2 to 12 weeks duration in total of 1255 pediatric patients 4 to 11 years of age with symptoms of seasonal or perennial allergic rhinitis. *The local nasal effects in children aged 4-11 years were similar to those reported in patients 12 years of age and older in clinical trials *Dosing information for children aged 4-11 years *The safety and effectiveness of QNASL Nasal Aerosol in children younger than 4 years of age have not been established
|
Labeling
|
|
P
|
|
|
Teva
|
|
|
Antiallergy
|
12/17/2014
|
Xtoro
|
finafloxacin
|
Treatment of acute otitis externa
|
*New approval *The safety and efficacy of XTORO in treating acute otitis externa in pediatric patients one year or older have been demonstrated in two randomized multicenter, vehicle controlled clinical trials in total of 1234 patients aged 6 months to 85 years. *PK analyses were performed in 14 healthy adult volunteers and 36 patients ages 6 years and older with AOE. *The safety and efficacy of XTORO below one year of age have not been established
|
Labeling
|
|
|
B, P
|
|
Alcon
|
08/25/2014
|
|
Anti-inflammatory, topical
|
12/19/2014
|
Merrem I.V.
|
meropenem
|
Complicated intra-abdominal infections
|
*Indication extended to pediatric patients less than 3 months of age with intra-abdominal infections *Efficacy for cIAI upported by evidence from adequate and well-controlled studies in adults with additional data from a pediatric PK and safety study *A PK study was conducted in pediatric patients less than 3 months of age, including preterm infants. *Dosing for patients with normal renal function in this age group is based on gestational age and postnatal age. *Off-patent Written Request.
|
[INVALID]
|
|
|
B
|
|
AstraZeneca
|
|
|
Antibiotic
|
12/23/2014
|
Taclonex
|
calcipotriene/ betamethasone dipropionate
|
Psoriasis vulgaris
|
*Extended the indication for psoriasis down to pediatric patients 12 to 17 years , based on adequate and well controlled studies in adults supported by a 4 week safety study in 33 patients 12 years and older. *Patients with plaque psoriasis involving 5-30% of the body surface area were treated with Taclonex Ointment for 4 weeks up to a maximum of 55.8 g per week. *Maximum weekly dose established (60 g per week)
|
Labeling
|
|
|
|
|
LEO Pharma
|
|
|
Vitamin D analog
|
12/29/2014
|
Gadavist
|
gadobutrol
|
Detection and visualization of areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system
|
*Extended the indication to pediatric patients from bith at age 37 weeks gestation up to 2 years of age, based on two adequate and well controlled studies in 44 ages 0 to less than 2 years and extrapolation from of adult CNS efficacy data *The frequency, type, and severity of adverse reactions in pediatric patients were similar to those in adults. *Dosing established [0.1 mL/kg body weight (0.1 mmol/kg)] *PK studies suggest that clearance of Gadavist is similar in pediatric patients and adults, including pediatric patients age younger than 2 years *Juvenile toxicity studies in rats did not reveal findings suggestive of a specific risk for use in pediatric patients including term neonates and infants
|
Labeling
|
|
P
|
|
|
Bayer
|
|
|
Medical Imaging
|
12/30/2014
|
Natroba
|
spinosad
|
Head lice infestation
|
*Extended the use of Natroba to pateints aged 6 months and older. *A 23-day open-label study assessed the pharmacokinetic profile of spinosad 0.9% and the ingredient benzyl alcohol in pediatric patients in 26 pediatric patients aged between 6 months to 4 years *Plasma spinosad and benzyl alcohol concentrations at 12 hours post-treatment were below limit of quantification for all subjects tested *Safety in pediatric patients below the age of 6 months has not been established
|
Labeling
|
|
P
|
|
|
ParaPRO
|
|
|
Pediculocide, topical
|
01/16/2015
|
Cutivate
|
fluticasone propionate
|
Atopic dermatitis
|
*Extended the use of Cutivate from patients aged 1 year and older down to 3 months and older *Reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression in 1 patient under 1 year *The safety and effectiveness of Cutivate Lotion in pediatric patients below 3 months of age have not been established
|
Labeling
|
|
P
|
|
|
Fougera Pharmaceuticals Inc.
|
|
|
Antiinflammatory, topical
|
01/22/2015
|
Xopenex Inhalation Solution
|
levalbuterol
|
Asthma or reactive airway disease
|
*Efficacy was not established in one adequate and well controlled trial in 291 pediatric patients from 2 to 5 years, and another adequate and well controlled trial of 88 pediatirc patients from birth to less than 2 years. *Adverse reactions in both studes were consistent with adverse reactions in patients 6 years and older. *Increased number of asthma-related adverse reactions following chronic XOPENEX treatment compared to control. *XOPENEX Inhalation Solution is not indicated for pediatric patients less than 6 years of age
|
Labeling
|
|
P
|
|
|
Oak Pharmaceuticals
|
|
|
Antiasthma
|
01/23/2015
|
BEXSERO
|
Meningococcal Group B Vaccine*
|
Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in patients 10 through 25 years of age
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Novartis Vaccines and Diagnostics, Inc
|
|
FALSE
|
Preventative Vaccine
|
01/30/2015
|
Pazeo
|
olopatadine hydrochloride
|
Ocular itching associated with allergic conjunctivitis
|
*Safety and effectiveness have been established in pediatric patients 2 years and older. Use in these pediatric patients is supported by evidence from adequate and well-controlled studies in adults and an adequate and well controlled study evaluating the safety in pediatric and adult patients *New formulation
|
Labeling
|
|
|
B, P
|
|
Alcon
|
|
|
Antihistamine, topical
|
02/06/2015
|
Dutrebis
|
lamivudine and raltegravir
|
Treatment of HIV-1 infection
|
*Indicated in adults and pediatric patients 6 - 16 years and weighing at least 30 kg *Should not be used in children below 6 years or in patients weighing less than 30 kg due to weight based dosing requirements in this patient population *Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue treatment as clinically appropriate *The PK of Dutrebis in the pediatric population has not been studied in clinical trials. Based on modeling and simulation using raltegravir PK data in adults, the PK of raltegravir in Dutrebis in children was projected to result in exposures that have been previously shown to be safe and efficacious in adults *Information on dosing *New drug
|
Labeling
|
|
P
|
|
|
Merck Sharp & Dohme Corp.
|
|
|
Antiviral
|
02/12/2015
|
Banzel
|
rufinamide
|
Adjunctive treatment of seizures associated with Lennox Gastaut Syndrome
|
*Safety and effectiveness have been established in pediatric patients down to 1 year; Previously approved in 4 years and older. *The effectiveness in patients in patients 1 to less than 4 years was based upon a bridging pharmacokinetic and safety study *Safety and effectiveness in pediatric patients below the age of 1 year has not been established *Adverse reactions were similar to those observed in adults and pediatric patients 4 years and older *Information on clinical trial, dosing and adverse reactions in 1 to less than 4 years
|
Labeling
|
B
|
|
|
|
Eisai Inc.
|
01/13/2015
|
|
Anticonvulsant
|
02/20/2015
|
Astepro Nasal Spray
|
azelastine
|
Seasonal allergic rhinitis; Perennial allergic rhinitis
|
*One 4-week open-label study of 191 pediatric patients from 6 months to 5 years established safety and reduced allergic rhinitis sympsoms. These data supported treatment of: * Seasonal allergic rhinitis in patients aged 2 though 6 years, including dosing information *Perennial allergich rhinitis in pediatric patients aged 6 months through 6 years, including dosing information. *The safety and effectiveness of ASTEPRO in patients below 6 months of age have not been established
|
Labeling
|
|
|
B, P
|
|
Meda
|
03/23/2015
|
|
Antiallergy
|
02/20/2015
|
Dymista
|
azelastine hydrochloride and fluticasone proprionate
|
Treatment of symptoms of seasonal allergic rhinitis
|
*Approved for use in pediatric patients 6 to 11 years based on safety and efficacy data from clinical studies of 416 patients and the established efficacy and safety of azelastine hydrochloride nasal spray and fluticasone propionate nasal spray in this age group; previously approved in 12 years and older *Safety findings in children 4-5 years of age were similar to those in children 6-11 years, but efficacy was not established *Safety and effectiveness of have not been studied in pediatric patients below the age of 4 years *Information on clinical trial and adverse reactions *Postmarketing study
|
Labeling
|
|
|
B, P
|
|
Meda
|
03/23/2015
|
|
Antiallergy
|
02/26/2015
|
Liletta
|
levonorgestrel-releasing intrauterine system
|
Prevention of pregnancy for up to 3 years
|
*Safety and efficacy have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal females under 16 years and for users 16 years and older *Use before menarche is not indicated *New drug
|
Labeling
|
|
P
|
|
|
Medicines360
|
|
TRUE
|
Contraceptive
|
03/12/2015
|
Saphris
|
asenapine
|
Treatment of Schizophrenia and Acute Manic or Mixed Episodes Associated with Bipolar I Disorder
|
*Bipolar I Disorder *Safety and efficacy were established in a 3-week, placebo-controlled, double-blind trial of 403 pediatric patients ages 10 to 17 years, at fixed doses ranging from 2.5 mg – 10 mg twice daily *Safety and efficacy in patients less than 10 years of age have not been evaluated *In a Phase 1 study, pediatric patients aged 10 to 17 years appeared to be more sensitive to dystonia when the recommended dose escalation schedule for initial dosing was not followed *Adverse reactions: somnolence, dizziness, dysgeusia, oral paresthesia, nausea, increased appetite, fatigue, increased weight. Fatigue dose related *Monitor weight compared to expectations for normal growth. Weight gain (greater than or equal to 7%. increase in body weight) higher than placebo , Saphris 2.5 mg twice daily, 5 mg twice daily and 10 mg twice daily (1.1%, 12%, 8.9% and 8 % respectively) *No additional new major safety findings were reported from a 50-week, open-label, uncontrolled safety *Safety and efficacy for adjunctive therapy in the treatment of bipolar I disorder have not been established in the pediatric population. *Schizophrenia *Efficacy was not demonstrated in an 8-week, placebo-controlled, double-blind trial, in 306 adolescent patients aged 12 to17 years with schizophrenia *Safety and efficacy in patients less than 12 years have not been evaluated, *The most common adverse reactions reported were somnolence, akathisia, dizziness, and oral hypoesthesia or paresthesia. * Monitor weight gain compared with tht expected for normal growth. Increases in body weight of at least 7% increase in body weight at endpoint compared to baseline for placebo, Saphris 2.5 mg twice daily, and Saphris 5 mg twice daily was 3%, 10%, and 10%, respectively *Adverse reactions identified in the pediatric schizophrenia trial were generally similar to those observed in the pediatric bipolar and adult bipolar and schizophrenia trials *No new major safety findings were reported from a 26-week, open-label safety trial in pediatric patients with schizophrenia treated with Saphris monotherapy *Information on dosing, adverse reactions, lab abnormalities, and clinical trials *Postmarketing study
|
Labeling
|
|
|
B, P
|
|
Forest
|
03/03/2015
|
|
Antipsychotic
|
03/12/2015
|
Xopenex HFA Inhalation
|
levalbuterol
|
Asthma or reactive airway disease
|
*Not indicated for pediatric patients less than 4 years of age. A 4 week randomized, placebo-controlled clinical trial in pediatric patients below the age of 4 years showed no statistical significant difference between treatment groups in the primary efficacy endpoint *There was an increased incidence of asthma-related adverse reactions reported in Xopenex HFA-treated pediatric patients compared to placebo in this age group *Information on clinical trial *Postmarketing study
|
Labeling
|
|
P
|
|
|
Sunovion Pharmaceuticals
|
|
|
Antiasthmatic
|
03/18/2015
|
Intuniv
|
guanfacine
|
Long-term maintenance treatment of ADHD
|
*Information added to labeling regarding a long-term, placebo-controlled monotherapy maintenance trial in 6-17 years *Increases in mean systolic and diastolic blood pressure, of approximately 3 mmHg and 1 mmHg respectively, above original baseline were observed upon discontinuation of Intuniv *Information on adverse reactions and clinical trial *Postmarketing study
|
Labeling
|
|
P
|
|
|
Shire
|
|
|
Non-stimulant ADHD treatment
|
03/23/2015
|
Ziagen
|
abacavir
|
HIV
|
* Labeling revised to provide for once-daily dosing in pediatric patients 3 months of age *Information on clinical trial *Postmarketing study
|
Labeling
|
|
P
|
|
|
ViiV Healthcare
|
|
|
Antiviral
|
03/23/2015
|
Epivir
|
lamivudine
|
HIV
|
* Labeling revised to provide for once-daily dosing in pediatric patients 3 months of age *Information on clinical trial *New dosing
|
Labeling
|
|
P
|
|
|
ViiV Healthcare
|
|
|
Antiviral
|
03/24/2015
|
Quadracel
|
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
|
Indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Sanofi Pasteur
|
|
|
Preventative vaccine
|
03/26/2015
|
Oraltag
|
iohexol
|
Computed tomography of the abdomen and pelvis
|
*Safety and effectiveness of oral iohexol have been established in pediatric patients *Information on dosing and preparation and administration instructions *New dosage form
|
Labeling
|
|
P
|
|
|
Interpharma Praha, a.s.
|
|
|
Medical Imaging
|
03/27/2015
|
Eovist
|
gadoxetate disodium
|
Postmarketing study
|
*An adequate and well-controlled study was not conducted. An observational study was performed in 52 patients 2 months and less than18 years with suspected or known focal liver lesions. Eovist improved border delineation and increased contrast of the lesion in the majority of patients when compared to non-contrast images. *Safety and effectiveness have not been established in premature infants *No new safety issues were identified *No case of nephrogenic systemic fibrosis associated with Eovist or any other Gadolinium-based contrast agent has been identified in pediatric patients ages 6 years and younger *Postmarketing study
|
Labeling
|
|
P
|
|
|
Bayer
|
|
|
Medical Imaging
|
03/31/2015
|
ProAir RespiClick
|
albuterol sulfate
|
Treatment or prevention of bronchospasm and prevention of exercise induced bronchospasm
|
*Safety and effectiveness for the treatment or prevention of bronchospasm in children 12 - 17 years and older with reversible obstructive airway disease is based on two12-week clinical trials, one long-term safety study and one -single-dose cross over study *The safety and effectiveness for treatment of exercise-induced bronchospasm in children 12 years of age and older is based on one single dose crossover study *The safety profile for patients 12 to 17 years was consistent with the overall safety profile seen in adults *The safety and effectiveness in pediatric patients below the age of 12 years have not been established. 120 children with asthma ages 4 to 11 years participated in the clinical program *Information on clinical trials, and adverse reaction information in adults and children 12 years and older *New dosage form
|
Labeling
|
|
P
|
|
|
Teva
|
|
|
Antiasthma
|
04/17/2015
|
Aptensio XR
|
methylphenidate hydrochloride
|
Attention Deficit Hyperactivity Disorder
|
*Safety and effectiveness of have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled clinical trials. * Safety and effectiveness in pediatric patients under six years have not been evaluated. *The long-term efficacy of methylphenidate in pediatric patients has not been established. * CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor weight and height in pediatric patients treated with CNS stimulants, including Aptensio XR. Pediatric patients not growing or gaining weight as expected may need to have their treatment interrupted. * Information on dosing, adverse reactions, and clinical trials
|
Labeling
|
|
P
|
|
|
Rhodes Pharmaceuticals L.P.
|
|
FALSE
|
CNS Stimulant
|
04/23/2015
|
Valcyte
|
valganciclovir
|
Prevention of cytomegalovirus disease in heart transplant patients
|
*Extended indication down to 1 to 4 months; previously approved in 4 months and older. *Extended the duration of dosing regimen from 100 days to 200 days post-transplantation for the prevention of CMV disease in pediatric kidney transplant patients 4 months to 16 years. *Safety and efficacy have not been established in children for prevention of CMV disease in pediatric liver transplant patients, in kidney transplant patients less than 4 months of age, in heart transplant patients less than 1 month of age, in pediatric AIDS patients with CMV retinitis, and in infants with congenital CMV infection. *Monitor serum creatinine levels regularly and consider changes in height and body weight and adapt the dose as appropriate during prophylaxis period. *Higher incidence of neutropenia in the two pediatric studies as compared to adults, but there was no correlation between neutropenia and infections observed in the pediatric population. *The overall safety profile was similar with the extension of prophylaxis until Day 200 posttransplant in high risk pediatric kidney transplant patients. However, the incidence of severe neutropenia was higher in pediatric kidney transplant patients treated with VALCYTE until Day 200 (17/57, 30%) compared to pediatric kidney transplant patients treated until Day 100 (3/63, 5%). *Information on dosing, pharmacokinetics, clinical studies
|
Labeling
|
|
P
|
|
|
Roche Palo Alto LLC
|
|
FALSE
|
Antiviral
|
04/27/2015
|
Tarceva
|
erlotinib
|
Recurrent or refractory ependymoma
|
*Safety and effectiveness in pediatric patients have not been established. * In an open-label, multi-center trial, 25 pediatric patients (median age 14 years, range 3-20 years) with recurrent or refractory ependymoma were randomized to Tarceva or etoposide. * Safety and effectiveness in pediatric patients have not been established. * In an open-label, multi-center trial, 25 pediatric patients (median age 14 years, range 3-20 years) with recurrent or refractory ependymoma were randomized to Tarceva or etoposide. * The trial was terminated prematurely for lack of efficacy. * No new adverse events were identified in the pediatric population. * Information on clinical trial and population pharmacokinetics
|
Labeling
|
B
|
|
|
|
OSI Pharmaceuticals, LLC
|
03/18/2015
|
FALSE
|
Antineoplastic
|
04/30/2015
|
Breo Ellipta
|
fluticasone furoate/vilanterol
|
Treatment of asthma
|
*Breo Ellipta is not indicated for use in children and adolescents. *The efficacy of Breo Ellipta was evaluated in 4 randomized, double-blind, parallel-group clinical trials in adolescent and adult patients with asthma. Adolescents aged 12 to 17 years made up 14% of the study population (n = 281). *Among the adolescents, asthma-related hospitalizations occurred in 4 patients (2.6%) treated with Breo Ellipta 100/25 compared with 0 patients treated with fluticasone furoate 100 mcg. There were no asthma-related deaths or asthma-related intubations observed in the adolescent age group. *Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to children and adolescents. *Information on clinical trials in adults and adolescents.
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE
|
Antiasthmatic
|
05/14/2015
|
Treximet
|
sumatriptan/naproxen
|
Acute treatment of migraine with or without aura
|
* Safety and efficacy for the acute treatment of migraine in pediatric patients 12 to 17 years of age were established in a double-blind, placebo-controlled trial *Safety and effectiveness in pediatric patients under 12 years of age have not been established *The safety of treating an average of more than 2 migraine headaches in pediatric patients in a 30-day period has not been established *Information on dosing, adverse reactions, pharmacokinetics clinical studies *Postmarketing study
|
Labeling
|
|
|
B, P
|
|
Pernix Therapeutics
|
04/16/2015
|
FALSE
|
Antimigraine
|
05/14/2015
|
IXINITY
|
Coagulation Factor IX (Recombinant)*
|
Indicated in adults and children equal to or greater than 12 years of age with hemophilia B for control and prevention of bleeding episodes, and for perioperative management
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Cangene Corporation
|
|
FALSE
|
Antihemophilic Factor
|
05/18/2015
|
Lamictal
|
lamotrigine
|
Maintenance treatment of bipolar disorder
|
* Safety and efficacy for the maintenance treatment of bipolar disorder were not established in a double-blind, placebo-controlled trial that evaluated 301 pediatric patients aged 10 to 17 *Information on clinical trial and adverse reactions *Postmarketing study
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE
|
Anticonvulsant; Mood Stablizer
|
05/27/2015
|
Asacol
|
mesalamine***
|
Maintenance of remission of mildly to moderately active ulcerative colitis
|
*Safety and effectiveness for the maintenance of remission of mildly to moderately active ulcerative colitis in pediatric patients have not been established *Efficacy was not demonstrated in a randomized, double-blind 26-week trial of two dosage levels in 39 patients aged 5 to 17 years
|
Labeling
|
B
|
|
|
|
Warner Chilcott
|
|
FALSE
|
Anti-inflammatory
|
06/12/2015
|
Zomig Nasal Spray
|
zolmitriptan
|
Acute treatment of migraine with or without aura in adolescents 12 to 17 years old
|
* Efficacy in pediatric patients 12 to 17 years was established in a placebo-controlled study with 81 pediatric patients receiving Zomig 2.5 mg and 229 pediatric patients receiving Zomig 5 mg * Safety of Zomig nasal spray in the acute treatment of migraine in pediatric patients 12 to 17 years of age was established i n two studies * Safety and effectiveness of in pediatric patients under 12 years have not been established * Adverse reactions were similar to those observed in adults * Information on dosing, clinical trials, adverse reactions * Postmarketing study
|
Labeling
|
|
P
|
|
|
AstraZeneca
|
|
FALSE
|
Antimigraine
|
06/19/2015
|
Fycompa
|
perampanel
|
Treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older
|
* Safety and efficacy in pediatric patients 12 years and older was established in a randomized double-blind, placebo-controlled, multicenter trial, which included 11 pediatric patients 12 to 16 years exposed to Fycompa; an additional 6 patients were treated with Fycompa in the open label extension of the study * Safety and effectiveness in pediatric patients less than 12 years of age have not been established * Adverse reactions were similar to those observed in adults * Information on dosing, PK, clinical studies, and adverse reactions * New indication
|
Labeling
|
|
P
|
|
|
Eisai Inc.
|
|
FALSE
|
Anticonvulsant
|
06/26/2015
|
Kaletra
|
lopinavir/ ritonavir
|
Treatment of HIV-1 infection
|
* Kaletra should not be administered once daily in pediatric patients. * A multicenter, open-label study evaluated the efficacy and safety of twice-daily versus once-daily dosing of Kaletra tablets dosed by weight in 173 virologically suppressed HIV-1 infected children. * New dosing regimen, postmarketing study.
|
|
|
P
|
|
|
AbbVie Inc.
|
|
FALSE
|
Antiviral
|
07/15/2015
|
TachoSil
|
Absorbable Fibrin Sealant Patch*
|
Secondary treatment of local bleeding in adult and pediatric patients undergoing hepatic resection surgery
|
See Package Insert for new information on biologics
|
|
|
P
|
|
|
Takeda
|
|
FALSE
|
|
07/15/2015
|
Epiduo Forte
|
adapalene and benzoyl peroxide
|
Treatment of acne vulgaris in patients 12 years and older
|
*New higher strength combination formulation approved in adults and patients 12 years and older. *Safety and effectiveness in pediatric patients under the age of 12 have not been established. *Information on PK, adverse reactions, and clinical trial in adults and pediatric patients. *New dosage form.
|
Labeling
|
|
P
|
|
|
Galderma
|
|
FALSE
|
Antiacne, topical
|
07/30/2015
|
Gammaplex
|
Immune Globulin Intravenous (Human) 5% Liquid*
|
Treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Bio Products Laboratory
|
|
FALSE
|
|
08/05/2015
|
Wilate
|
von Willebrand Factor/Coagulation Factor VIII Complex (Human)*
|
On-demand treatment and control of bleeding episodes and perioperative management of bleeding
|
See Package Insert for new information on biologics
|
|
|
P
|
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H.
|
|
FALSE
|
Coagulation Factor
|
08/13/2015
|
Oxycontin extended release tablets
|
oxycodone hydrochloride
|
Management of pain severe enough to require daily, around the-clock, long-term opioid treatment in pediatric patients 11 years and older
|
*Safety and efficacy have been established in pediatric patients 11 to 16 years. Use is supported by evidence from adequate and well-controlled trials in adults as well as an open-label study in pediatric patients ages 6 to 16 years. *There were insufficient numbers of patients less than 11 years of age enrolled in this study to establish the safety of the product in this age group. *The safety in pediatric patients was evaluated in 155 patients previously receiving and tolerating opioids for at least 5 consecutive days. *The most frequent adverse reactions observed in pediatric patients were vomiting, nausea, headache, pyrexia, and constipation. *Information on dosing, adverse reactions, and clinical trial
|
Labeling
|
B
|
|
|
|
Purdue Pharma L.P.
|
|
FASLE
|
Analgesic
|
08/14/2015
|
Procysbi
|
cysteamine bitartrate
|
Treatment of nephropathic cystinosis in pediatric patients 2 years of age and older
|
*Expanded indication to pediatric patients down to 2 years; previously approved in 6 years and older. *Safety and effectiveness in pediatric patients under 2 years of age have not been established. *Information on adding capsule contents to foods and liquids. *Information on dosing, and clinical trial extension
|
Labeling
|
B
|
|
|
|
Raptor Pharmaceuticals, Inc.
|
|
FALSE
|
|
08/24/2015
|
Promacta
|
eltrombopag
|
Treatment of thrombocytopenia in adult and pediatric patients one year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy
|
*Safety and efficacy in pediatric patients 1 year and older with chronic ITP were evaluated in two double-blind, placebo-controlled trials. *Safety and efficacy in pediatric patients younger than 1 year with ITP have not yet been established. *Safety and efficacy in pediatric patients with thrombocytopenia associated with chronic hepatitis C and severe aplastic anemia have not been established. *Patients with East Asian ancestry have higher eltrombopag exposure. Dosing adjustments are needed in pediatric patients 6 years and older with East Asian ancestry and in hepatic impairment. *Information on dosing, preparation of oral suspension, PK parameters, clinical trials, adverse events.
|
Labeling
|
B
|
|
|
|
Novalar Pharmaceuticals, Inc.
|
08/19/2015
|
FALSE
|
|
08/26/2015
|
Edurant
|
rilpivirine
|
HIV-1 infection in treatment-naïve pediatric patients from 12 to less than 18
|
*Expanded the indication from adults to pediatric patients 12 to less than 18 years and weighing at least 32 kg. *Safety, efficacy and PK were evaluated in an open-label, Phase 2 trial that enrolled 36 antiretroviral treatment-naïve, HIV-1 infected pediatric patients. *Safety and effectiveness in pediatric patients less than 12 years have not been established. *Information added to Warnings on pediatric depression: During the Phase 2 trial, the incidence of depressive disorders was 19.4% (7/36). Most events were mild or moderate. The incidence of Grade 3 and 4 depressive disorders was 5.6% (2/36). Suicidal ideation and suicide attempt were reported in 1 subject. *The most common ADRs reported in at least 2 subjects (regardless of severity) include headache (19.4%), depression (19.4%), somnolence (13.9%), nausea (11.1%), dizziness (8.3%), abdominal pain (8.3), vomiting (5.6%) and rash (5.6%). *Information on dosing, adverse reactions, abnormal adrenal function, PK, and clinical trial
|
Labeling
|
|
|
B, P
|
|
Janssen
|
|
FALSE
|
|
08/28/2015
|
Emend
|
aprepitant
|
Prevention of chemotherapy induced nausea and vomiting in patients ages 12 years to 17 years and patients less than 12 years who weigh at least 30 kg
|
*Indicated for the prevention of nausea and vomiting associated with highly emetogenic cancer (HEC) chemotherapy and moderately emetogenic cancer (MEC) chemotherapy in patients 12 years of age and older and patients less than 12 years who weigh at least 30 kg. *Although the safety and efficacy results from the trial in 302 pediatric patients support the use of Emend for the prevention of nausea and vomiting associated with HEC or MEC in pediatric patients 6 months to 12 years, there is no commercially available dosage form appropriate for patients less than 12 years of age and weighing less than 30 kg. *Safety and effectiveness for the prevention of nausea and vomiting associated with HEC or MEC have not been established in patients less than 6 months. *Safety and effectiveness have not been established for the prevention of postoperative nausea and vomiting in pediatric patients. *Adverse reactions were similar to those observed in adults. *Information on dosing, adverse events, PK, and clinical trial
|
Labeling
|
|
|
B, P
|
|
Merck Sharp & Dohme Corp.
|
|
FALSE
|
Antiemetic
|
09/04/2015
|
NUWIQ
|
Antihemophilic Factor (Recombinant)*
|
Indicated in adults and children with Hemophilia A fr on-demand treatment and control of bleeding episodes, perioperative management of bleeding and routine prophylaxis to reduce the frequency of bleeding episodes
|
See Package Insert for new information on biologics
|
|
|
P
|
|
|
Octapharma USA, Inc.
|
|
FALSE
|
Antihemophilic Factor
|
09/09/2015
|
Delzicol
|
mesalamine**
|
Treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older
|
*Expanded the indication to pediatric patients 5 years and older; previously approved in 12 years and older. *Safety and effectiveness in pediatric patients below the age of 5 years have not been established. *Two Delzicol 400 mg capsules have not been shown to be interchangeable or substitutable with one mesalamine delayed-release 800 mg tablet. *For patients unable to swallow the capsules whole, information on opening the capsule(s) and swallowing the contents. *New dosage form
|
Labeling
|
|
|
B, P
|
|
Warner Chilcott
|
|
FALSE
|
Anti-inflammatory
|
09/14/2015
|
Velcade
|
bortezomib
|
Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
|
*Effectiveness in pediatric patients with relapsed pre-B ALL has not been established. *The activity and safety of Velcade in combination with intensive reinduction chemotherapy was evaluated in pediatric and young adult patients with lymphoid malignancies. There were 140 patients with ALL or LL enrolled and evaluated for safety. *No new safety concerns were observed
|
Labeling
|
B
|
|
|
|
Millennium Pharmaceuticals, Inc.
|
|
FALSE
|
Antineoplastic
|
09/15/2015
|
Spiriva Respimat Inhalation Spray
|
tiotropium bromide
|
"Long-term, once-daily, maintenance treatment of asthma in patients 12
|
*Safety and efficacy Spiriva Respimat 2.5 mcg have been established in patients 12 to 17 years with asthma in 3 clinical trials up to 1 year in duration. *In 3 clinical trials, 327 patients aged 12 to 17 years with asthma were treated with Spiriva Respimat 2.5 mcg. *Safety and efficacy of Spiriva Respimat have not been established in pediatric patients less than 12 years of age. *Adverse reactions in adolescents were similar to those observed in adults. *Information on dosing, adverse reactions and clinical trials in adults and adolescents. *New indication
|
Labeling
|
|
P
|
|
|
Boehringer Ingelheim
|
|
FALSE
|
Antiasthmatic
|
09/17/2015
|
Epzicom
|
abacavir sulfate and lamivudine
|
Once-daily dosing for the treatment of HIV-1 infection in pediatric patients weighing at least 25 kg
|
*Expanded indication from adults to pediatric patients weighing at least 25kg. *Dosing recommendations in this population are based on the safety and efficacy established in a controlled trial conducted using either the combination of Epivir and Ziagen or Epzicom. *In pediatric patients weighing less than 25 kg, use of abacavir and lamivudine as single products is recommended. *The adverse reactions in pediatric patients are similar to those observed in adults. *Information on dosing, PK, clinical studies.
|
Labeling
|
|
P
|
|
|
ViiV Healthcare
|
|
|
Antiviral
|
09/24/2015
|
Reyataz Oral Powder
|
atazanavir
|
HIV-1
|
*Expanded indication to patients 3 months and older weighing 5 to < 10 kg and to those weighing > 25 kg; previously approved in patients 3 months of age and older weighing at least 10 kg. *Not recommended for patients weighing less than 5 kg. *Information on PK, dosing and clinical trial. *Postmarketing study
|
|
|
|
B, P
|
|
|
|
FALSE
|
Antiviral
|
10/19/2015
|
Dyanavel XR
|
amphetamine
|
Treatment of Attention Deficit Hyperactivity Disorder in 6 years and older
|
*Safety and effectiveness have been established in pediatric patients with ADHD ages 6-17 years. *Safety and efficacy in pediatric patients younger than 6 years with ADHD have not been established. *Growth should be monitored during treatment with stimulants, including Dyanavel XR, and children who are not growing or gaining weight as expected may need to have their treatment interrupted. *The adverse reaction profile of Dyanavel XR appears similar to other amphetamine extended-release products. *Information on adverse reactions, dosing, PK, and clinical trial. *New dosage form
|
Labeling
|
B
|
|
|
|
Tris Pharma, Inc.
|
|
FALSE
|
CNS Stimulant
|
11/04/2015
|
Nucala
|
mepolizumab
|
Treatment in severe asthma in patients 12 years and older older and with an eosinophilic phenotype
|
*Indicated for adults and pediatric patients 12 years and older * A total of 28 adolescents aged 12 to 17 years with asthma were enrolled in the phase 3 studies. *Safety and efficacy in pediatric patients less than 12 years have not been established. *Information on dosing, and clinical trials *New drug
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE
|
Antiasthmatic
|
11/05/2015
|
Genvoya
|
elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide
|
Treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older
|
*Indicated for adults and pediatric patients 12 years and older weighing at least 35 kg. *The pharmacokinetics, safety, and virologic and immunologic responses were evaluated in 23 treatment-naïve, HIV-1 infected patients 12 to less than 18 years through 24 weeks in an open-label trial *Safety and effectiveness in pediatric patients less than 12 years have not been established.*Among the 23 pediatric patients receiving Genvoya for 24 weeks, 2 patients had significant (greater than 4%) lumbar spine BMD loss at Week 24.*Information on dosing, PK, adverse reactions and clinical trials *New drug
|
Labeling
|
|
P
|
|
|
Gilead Sciences
|
|
FALSE
|
Antiviral
|
11/13/2015
|
ADYNOVATE
|
Antihemophilic Factor (Recombinant), PEGylated*
|
Adolescent and adult patients (12 years and older) with hemophilia A (congenital factor VIII deficiency) for (1) on-demand treatment and control of bleeding episodes and (2) routine prophylaxis to reduce the frequency of bleeding episodes
|
See Package Insert for new information on biologics
|
|
|
P
|
|
|
Baxalta US Inc.
|
|
FALSE
|
|
11/18/2015
|
Narcan Nasal Spray
|
naloxone hydrochloride
|
Emergency treatment of known or suspected opioid overdose
|
*Safety and effectiveness of naloxone nasal spray have been established in adults and pediatric patients of all ages *Use of naloxone hydrochloride in pediatric patients is supported by evidence from adequate and well-controlled studies of naloxone hydrochloride in adults with additional data from 15 clinical studies (controlled and uncontrolled) in neonates and pediatric patients *Absorption of naloxone hydrochloride following intranasal administration in pediatric patients may be erratic or delayed. *Even when the opiate-intoxicated pediatric patient responds appropriately to naloxone hydrochloride, he/she must be carefully monitored for at least 24 hours, as a relapse may occur as naloxone is metabolized. *Use in patients who are opioid dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal. *Information on dosing *New dosage form
|
Labeling
|
|
P
|
|
|
Adapt Pharma Operations Limited
|
|
FALSE
|
Opioid antagonist
|
11/20/2015
|
Caldolor Injection
|
ibuprofen
|
Management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics, and for the reduction of fever in pediatric patients 6 months and older
|
*Expanded the indication down to pediatric patients 6 months and older; previously approved in adults *The effectiveness for the treatment of pain and fever has not been studied in pediatric patients less than 6 months. *Information on dosing, adverse reactions, and clinical trials *Postmarketing study
|
Labeling
|
|
P
|
|
|
Cumberland Pharmaceuticals, Inc
|
|
FALSE
|
Analgesic; Antipyretic
|
12/04/2015
|
QuilliChew ER
|
methylphenidate hydrochloride
|
Attention Deficit Hyperactivity Disorder
|
*Indicated for use in pediatric patients pediatric patients ages 6 to 17 years. *Use in these age groups is based on one adequate and well-controlled clinical study in pediatric patients 6 to 12 years old, pharmacokinetic data in adolescents and adults, and safety information from other methylphenidate-containing products. *The safety and effectiveness of in pediatric patients under six years have not been evaluated. *Long-term effectiveness of QuilliChew ER has not been established. *Growth should be monitored during treatment with CNS stimulants, including QuilliChew ER. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted. *Information on dosing, adverse events, clinical trial. *New dosage form.
|
Labeling
|
|
P
|
|
|
Pfizer
|
|
FALSE
|
CNS stimulant
|
12/04/2015
|
Gamunex-C
|
Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified*
|
Primary Humoral Immunodeficiency in patients two years of age and older
|
See Package Insert for new information on biologics
|
http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM069968.pdf
|
|
P
|
|
|
Grifols Therapeutics Inc.
|
|
FALSE
|
|
12/10/2015
|
Otiprio
|
ciprofloxacin otic suspension
|
Treatment of pediatric patients 6 months and older with bilateral otitis media with effusion undergoing tympanostomy tube placement
|
*Indicated in pediatric patients 6 months and older. *Safety and effectiveness was established in 530 pediatric patients with bilateral otitis media with middle ear effusion undergoing myringotomy with tympanostomy tube placement. The median age of patients enrolled in the clinical trials was 1.5 years. *The safety and effectiveness in infants below six months of age have not been established. *Information on administration, adverse reactions, and clinical trials. *New drug.
|
Labeling
|
|
P
|
|
|
Otonomy, Inc.
|
|
FALSE
|
Antibiotic, topical
|
12/17/2015
|
Emend
|
aprepitant**
|
Prevention of chemotherapy induced nausea and vomiting in patients ages 6 months of age and older
|
*Safety and effectiveness of Emend oral suspension have been established in pediatric patients 6 months and older. *Safety and effectiveness have not been established in patients less than 6 months. *New dosage form.
|
|
|
|
B, P
|
|
Merck Sharp & Dohme Corp.
|
|
FALSE
|
Antiemetic
|
01/11/2016
|
E-Z-HD
|
barium sulfate
|
For use in double contrast radiographic examinations of the esophagus, stomach and duodenum to visualize the gastrointestinal tract in patients 12 years and older
|
*Approved for use in adults and pediatric patients 12 years and older *Safety and efficacy have not been approved in pediatric patients less than 12 years of age * Information on dosing, adverse reactions *New drug
|
Labeling
|
|
P
|
|
|
Bracco Diagnostics
|
|
FALSE
|
Medical imaging
|
01/14/2016
|
HIBERIX
|
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) *
|
Active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b in children 6 weeks through 4 years of age
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline Biologicals
|
|
FALSE
|
Vaccine
|
01/15/2016
|
Readi-Cat 2 and Readi-Cat 2 Smoothie
|
barium sulfate
|
CT of the abdomen in pediatric patients
|
*Approved for use in adults and pediatric patients *Information in dosing, adverse reactions *New dosage form
|
|
|
P
|
|
|
Bracco Diagnostics
|
|
FALSE
|
Medical imaging
|
01/27/2016
|
Adzenys XR-ODT
|
amphetamine
|
Attention Deficit Hyperactivity Disorder in pediatric patients 6 to 17
|
* Safety and effectiveness have been established in pediatric patients 6 to 17 years in three clinical trials of up to 4 weeks in duration * Safety and efficacy in pediatric patients younger than 6 years of age have not been established. *Growth should be monitored during treatment with stimulants, including Adzenys XR-ODT, in pediatric patients 6 to 17 years who are not growing or gaining weight as expected because they may need to have their treatment interrupted. *Pediatric patients ages 6 to 12 years: Most common adverse reactions were loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever. Pediatric patients ages 13 to 17 years: Most common adverse reactions were loss of appetite, insomnia, abdominal pain, weight loss, and nervousness. *Information on dosing, adverse reactions, and clinical trials *New dosage form
|
Labeling
|
|
P
|
|
|
Neos Therapeutics, Inc.
|
|
FALSE
|
CNS Stimulent
|
02/03/2016
|
Prilosec
|
omeprazole magnesium
|
Short term treatment of erosive esophagitis due to gastroesophageal reflux disease in patients 1 month to less than 1 year of age
|
* Safety and effectiveness have been established in pediatric patients 1 month to less than 1 year of age. * Use in this population is supported by adequate and well-controlled studies in adults and safety, pharmacokinetic, and pharmacodynamic studies performed in pediatric patients. * Safety and efficacy have not been establish in patients less than 1 month of age for any indication. *Adverse reactions frequently reported in the 1 month to <1 year age group include respiratory adverse reactions (42%), and otitis media (22%). Information on dosing, PK, adverse reactions. *Postmarketing study
|
Labeling
|
|
P
|
|
|
AstraZeneca
|
|
FALSE
|
Antiulcerative
|
02/23/2016
|
Complera
|
emtricitabine/rilpivirine/tenofovir disoproxil fumarate
|
Treatment of HIV-1 infection
|
* Extended the indication from adults to pediatric patients in 12 to less than 18 years. *Safety and efficacy have not been established in pediatric patients less than 12 years or weighing less than 35 kg. * Pediatric trials have not been conducted using the emtricitabine, rilpivirine, tenofovir disoproxil fumarate fixed-dose combination tablets. Pediatric information is based on trials conducted with the individual entities. * Information on pharmacokinetics, and dosing. * Postmarketing study.
|
Labeling
|
|
P
|
|
|
Gilead
|
|
TRUE
|
Antiviral
|
02/24/2016
|
Aczone Gel 7.5%
|
dapsone
|
Treatment of acne vulgaris in patients 12 years of age and older
|
* Approved in adults and pediatric patients 12 years and older. * Safety and efficacy was evaluated in 1066 patients 12-17 years old. * Safety and effectiveness have not been established in pediatric patients below the age of 12 years. * Safety was similar to the vehicle control group. * Information on clinical trials, and adverse reactions in adults and pediatric patients 12 and older. * New Drug
|
Labeling
|
|
P
|
|
|
Allergan
|
|
FALSE
|
Anti-inflammatory, topical
|
02/29/2016
|
Tetracaine Hydrochloride Ophthalmic Solution
|
tetracaine hydrochloride
|
For use in procedures requiring a rapid and short-acting topical ophthalmic anesthetic
|
* Approved for use in adults and pediatric patients. * Safety in the pediatric population has been demonstrated in clinical trials. Efficacy for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population. * Information on dosing. * New drug.
|
Labeling
|
|
P
|
|
|
Alcon Research, Ltd.
|
|
TRUE
|
Antibiotic, topical
|
03/01/2016
|
Odefsey
|
emtricitabine, rilpivirine, and tenofovir alafenamide
|
Treatment of HIV-1 infection in patients 12 years of age and older
|
* Safety and efficacy of Odefsey was established in pediatric patients 12 years and older weighing 35 kg or more. * Use of Odefsey in this age group is supported by adequate and well-controlled studies in adults with HIV-1 infection, and by 2 pediatric studies in 59 pediatric patients 12 to < 18 years. * Safety and efficacy have not been established in pediatric patients less than 12 years of age or weighing less than 35 kg. * Safety was similar to that observed in adults. * Information on clinical trials, adverse reactions. * New drug
|
Labeling
|
|
P
|
|
|
Gilead Sciences
|
|
FALSE
|
Antiviral
|
03/10/2016
|
Truvada
|
emtricitabine/tenofovir disoproxil fumarate
|
Treatment of HIV-1 infection in pediatric patients weighing at least 17 kilograms
|
* Expanded the indication from pediatric patients 12 years and older down to pediatric patients weighing at least 17 kg. * Truvada should only be administered to HIV-1 infected pediatric patients with body weight greater than or equal to 17 kg and who are able to swallow a whole tablet. *Truvada has not been evaluated for use in pediatric patients weighing less than 17 kg. *Postmarketing study
|
Labeling
|
|
P
|
|
|
Gilead Sciences
|
|
FALSE
|
Antiviral
|
03/16/2016
|
KOVALTRY
|
Antihemophilic Factor (Recombinant), Full Length*
|
"Indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for: • On-demand treatment and control of bleeding episodes • Perioperative management of bleeding • Routine prophylaxis to reduce the frequency of bleeding episodes"
|
See Package Insert for new information on biologics
|
|
|
P
|
|
|
Bayer HealthCare LLC
|
|
FALSE
|
Antihemophilic Factor
|
03/18/2016
|
OraVerse Injection
|
phentolamine mesylate
|
Reversal of soft-tissue anesthesia
|
* Expanded indication down to pediatric patients 3 years and older; previously approved in 6 years and older. * Safety and efficacy have not been established in patients younger than 3 years. • Information on dosing and PK. * Postmarketing study
|
Labeling
|
|
P
|
|
|
Septodent Holding SAS
|
|
FALSE
|
|
03/18/2016
|
Anthim
|
obiltoxaximab
|
Treatment of inhalational anthrax in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax
|
* The effectiveness in adults and pediatric patients is based solely on efficacy studies in animal models of inhalational anthrax. * There have been no studies of safety or PK of ANTHIM in the pediatric population. * Information on dosing. * New drug
|
Labeling
|
|
P
|
|
|
Elusys Therapeutics, Inc.
|
|
FALSE
|
|
03/23/2016
|
Cinqair
|
reslizumab
|
Asthma in patients 12 to 17 years
|
* The safety and effectiveness in pediatric patients have not been established. * CINQAIR was evaluated in 39 patients aged 12 to less than 18 years with asthma in two 52-week exacerbation studies and one 16-week lung function study. In these studies, the asthma exacerbation rate was higher in adolescent patients treated with CINQAIR than placebo. * Information on clinical trials. * New drug
|
Labeling
|
|
P
|
|
|
Teva Respiratory, LLC
|
|
FALSE
|
Antiasthmatic
|
03/31/2016
|
Lumason
|
Sulfur Hexafluoride Lipid-Type A Microspheres
|
Ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
|
* Effectiveness in pediatric patients has been established for use in ultrasonography of the liver for characterization of focal liver lesions from adequate and well controlled trials in adult patients and a clinical study of 44 pediatric patients. Safety was based on evaluation of published literature involving use of Lumason in over 900 pediatric patients. Non-fatal anaphylaxis was reported in one pediatric patient. * New indication
|
Labeling
|
|
P
|
|
|
Bracco Diagnostics
|
|
FALSE
|
Medical Imaging
|
04/04/2016
|
Descovy
|
emtricitabine and tenofovir alafenamide
|
Treatment of HIV-1 infection in adults and pediatric patients 12 years of age or older
|
* Efficacy and safety of Descovy was established in pediatric patents aged 12 years old with body weight greater than or equal to 35 kg. * Safety and effectiveness in pediatric patients less than 12 years or less than 35 kg have not been established. * Assessment of Bone Mineral Density should be considered for adults and pediatric patients treated with Descovy who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. * Information on dosing, clinical trial and PK. * New drug.
|
Labeling
|
|
P
|
|
|
Gilead Sciences
|
|
FALSE
|
Antiviral
|
04/14/2016
|
Trumenba
|
Meningococcal Group B Vaccine *
|
Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B
|
See Package Insert for new information on biologics
|
|
|
P
|
|
|
Wyeth
|
|
FALSE
|
Vaccine
|
04/27/2016
|
Gadavist
|
gadobutrol
|
Evaluation of known or suspected supra-aortic or renal artery disease in adult and pediatric patients
|
* Approved for use in adults and pediatric patients, including term neonates, to evaluate known or suspected supra-aortic or renal artery disease. * Information on clinical trials. * New indication.
|
Labeling
|
|
P
|
|
|
Bayer
|
|
FALSE
|
Medical Imaging
|
04/28/2016
|
ProAir RespiClick
|
albuterol sulfate
|
Asthma in pediatric patients between the ages 4 to 11 years
|
* Expanded the indication down to pediatric patients 4-11 years; previously approved in 12 years and older. * Safety and effectiveness in pediatric patients below the age of 4 years have not been established. * Information on dosing, adverse reactions, and clinical trials. * Postmarketing study
|
Labeling
|
|
P
|
|
|
Teva
|
|
FALSE
|
Antiasthmatic
|
04/29/2016
|
Fycompa
|
perampanel
|
Adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy 12 years of age and older and as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older
|
* New Fycompa oral suspension has comparable bioavailability to Fycompa tablets under steady state. Both formulations may be used interchangeably. *Measure oral suspension using provided adaptor and dosing syringe. * Information on administration of oral suspension. *New formulation.
|
Labeling
|
|
P
|
|
|
Eisai Inc.
|
|
FALSE
|
Anticonvulsant
|
04/29/2016
|
Otovel Otic Solution
|
ciprofloxacin and fluocinolone acetonide
|
Treatment of acute otitis media with tympanostomy tubes in pediatric patients 6 months and older
|
* Approved for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients aged 6 months and older, * Information on dosing, and clinical trials. * New drug.
|
Labeling
|
|
P
|
|
|
Laboratorios SALVAT, S.A.
|
|
FALSE
|
antibiotic/anti-inflammatory
|
04/29/2016
|
Entocort EC
|
budesonide
|
Treatment of mild to moderate active Crohn's disease in patients 8 years of age and older, and maintenance of remission in Crohn’s disease in patients ages zero to 17 years of age
|
Mild to moderate active Crohn's disease * Safety and effectiveness have been established in pediatric patients 8 to 17 years who weigh more than 25 kg for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon. * Use in this age group is supported by evidence from adequate and well controlled studies of Entocort EC in adults, with additional data from 2 clinical studies in 149 pediatric patients treated up to 8 weeks and one pharmacokinetic study in 8 pediatric patients. * Safety and effectiveness have not been established in pediatric patients less than 8 years of age. Maintenance of remission in Crohn’s disease * Safety and effectiveness have not been established in pediatric patients for the maintenance of clinical remission of mild to moderate Crohn’s disease. * An open-label study to evaluate the safety and tolerability as maintenance treatment in pediatric patients aged 5 to 17 years did not establish the safety and efficacy of maintenance of clinical remission. * Safety profile is similar to safety profile observed in adults and no new safety concerns were identified. * Systemic corticosteroids, including Entocort EC, may cause a reduction of growth velocity in pediatric patients. * Pediatric patients with Crohn’s disease have a 17% higher mean systemic exposure and cortisol suppression than adults with Crohn’s disease. *Information on dosing, safety, clinical trials and PK. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
Elan
|
|
FALSE
|
Anti-inflammatory
|
05/23/2016
|
Flucelvax Quadrivalent
|
Influenza Vaccine*
|
For active immunization of children and adolescents 4 years of age and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Seqirus, Inc.
|
|
FALSE
|
Preventive Vaccine
|
05/23/2016
|
Flucelvax
|
Influenza Vaccine*
|
For active immunization of persons 4 years of age and older for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Seqirus, Inc.
|
|
FALSE
|
Preventive Vaccine
|
05/25/2016
|
AFSTYLA
|
Antihemophilic Factor (Recombinant), Single Chain*
|
Indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for: (1) On-demand treatment and control of bleeding episodes, (2) Routine prophylaxis to reduce the frequency of bleeding episodes, and (3) Perioperative management of bleeding
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
CSL Behring AG
|
|
FALSE
|
Antihemophilic Factor
|
05/27/2016
|
Ativan Injection
|
lorazepam
|
Status epilepticus
|
*Safety and effectiveness for status epilepticus have not been established in pediatric patients. *A randomized, double-blind, superiority-design clinical trial of Ativan versus intravenous diazepam in 273 pediatric patients ages 3 months to 17 years failed to establish efficacy for the treatment of status epilepticus. *Information on adverse reactions, and clinical trial. *Off-patent Written Request.
|
|
B
|
|
|
|
Eurohealth International SARL
|
|
FALSE
|
Anticonvulsant
|
05/27/2016
|
Teflaro Injection
|
ceftaroline fosamil
|
Acute Bacterial Skin and Skin Structure Infections (ABSSI) and Community Acquired Bacterial Pneumonia (CABP) in pediatric patients 2 months to less than 18 years
|
*Safety and effectiveness of Teflaro in the treatment of ABSSI and CABP have been established in pediatric patients 2 months to less than 18 years. *Use of Teflaro in these age groups is supported by evidence from adequate and well-controlled studies of Teflaro in adults with additional pharmacokinetic and safety data from pediatric trials. *Safety and effectiveness in pediatric patients below the age of 2 months have not been established as no data are available. *Safety findings were similar to those seen in the adult studies. *Information on dosing, PK , and adverse reactions. *Postmarketing study
|
Labeling
|
|
P
|
|
|
Cerexa, Inc.
|
|
FALSE
|
Antibiotic
|
06/09/2016
|
Tivicay
|
dolutegravir
|
Treatment naïve or treatment experienced INSTI-naïve pediatrics patients weighing at least 30 kg to less than 40 kg
|
*Expanded the indication to pediatrics patients weighing at least 30 kg; previously approved in 12 years and older weighing at least 40 kg * Safety and efficacy have not been established in pediatric patients weighing less than 30 kg or in any pediatric patients who are INSTI-experienced *Adverse reactions were similar to those observed in adults *Information on dosing, PK, and adverse reactions *Postmarketing study
|
Labeling
|
|
P
|
|
|
ViiV Healthcare
|
|
FALSE
|
Antiviral
|
06/29/2016
|
Kovanaze Nasal Spray
|
tetracaine HCl and oxymetazoline HCl
|
Regional anesthesia when performing a restorative procedure on teeth 4-13 and A-J in adults and children who weigh 40 kg or more
|
*Approved in adults and children who weigh 40 kg or more *Kovanaze has not been studied in pediatric patients under 3 years and is not advised for use in pediatric patients weighing less than 40 kg because efficacy has not been demonstrated in these patients *Information on adverse reactions in adults and pediatric patients, clinical trial, PK * New drug
|
Labeling
|
|
P
|
|
|
St. Renatus, LLC
|
|
FALSE
|
Anesthetic, topical
|
07/06/2016
|
Xolair
|
omalizumab
|
Moderate to severe persistent asthma in pediatric patients 6 to 11 years of age
|
*Safety and efficacy of Xolair for asthma were evaluated in 2 trials in 926 (Xolair 624; placebo 302) pediatric patients 6 to <12 years of age with moderate to severe persistent asthma. *Safety and efficacy in pediatric patients with asthma below 6 years of age have not been established. *Information on dosing, immunogenicity, adverse reactions, clinical trials. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
Genentech
|
|
FALSE
|
Antiasthmatic
|
07/08/2016
|
Dexilant
|
dexlansoprazole
|
Healing of erosive esophagitis (EE), maintenance of healed EE and relief of heartburn, and treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD) in 12 to 17 years
|
*Safety and effectiveness of Dexilant capsules have been established in pediatric patients 12 to 17 years for the healing of all grades of EE. *The safety and effectiveness of Dexilant capsules and Dexilant SoluTab have been established in pediatric patients 12 to 17 years for the maintenance of healed EE and relief of heartburn, and treatment of heartburn associated with symptomatic non-erosive GERD. *Use in this age group is supported by evidence from adequate and well-controlled studies of Dexilant capsules in adults with additional safety, efficacy and pharmacokinetic data in pediatric patients 12 to 17 years. *Safety and effectiveness have not been established in pediatric patients less than 12 years. *Use of Dexilant is not recommended for symptomatic non-erosive GERD in pediatric patients less than 1 year because studies in this class of drugs have not demonstrated efficacy. *Adverse reactions similar to those observed in adults. *Information on dosing, adverse reactions, clinical trials. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
Takeda
|
|
FALSE
|
Antiulcerative
|
07/12/2016
|
Effient
|
prasugrel
|
Vaso-occlusive crises in pediatric patients with sickle cell disease
|
*Safety and effectiveness in pediatric patients have not been established. *In a randomized, placebo-controlled trial, the primary objective of reducing the rate of vaso-occlusive crisis in pediatric patients, aged 2 to less than 18 years, with sickle cell anemia was not met.
|
|
|
|
B
|
|
Lilly
|
05/23/2016
|
FALSE
|
|
07/29/2016
|
Dysport
|
abobotulinumtoxinA
|
Treatment of lower limb spasticity in pediatric patients 2 years of age and older
|
*Indicated for the treatment of lower limb spasticity in pediatric patients 2 years and older. *Safety and effectiveness in pediatric patients with lower limb spasticity below 2 years of age have not been evaluated. *Safety and effectiveness of Dysport injected into proximal muscles of the lower limb for the treatment of spasticity in pediatric patients has not been established. *The most commonly observed adverse reactions were upper respiratory tract infection, nasopharyngitis, influenza, pharyngitis, cough and pyrexia. *Information on dosing, preparation and administration, adverse reactions, and clinical trial. *New indication.
|
Labeling
|
|
P
|
|
|
Ipsen Biopharmaceuticals, Inc.
|
|
FALSE
|
neuromuscular blocking agent
|
08/16/2016
|
Kapvay
|
clonidine
|
Postmarketing study
|
*In studies in juvenile rats, clonidine hydrochloride alone or in combination with methylphenidate had an effect on bone growth at clinically relevant doses and produced a slight delay in sexual maturation in males at 3 times the maximum recommended human dose (MRHD) for clonidine and methylphenidate. *Juvenile rat studies also showed a decrease in bone mineral density, mineral content, and decreased femur length. Decreased body weight was also observed. *Postmarketing study.
|
|
|
P
|
|
|
Concordia Pharmaceuticals, Inc.
|
|
FALSE
|
Non-stimulant ADHD treatment
|
08/30/2016
|
Blincyo
|
blinatumomab
|
Treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
|
*Safety and efficacy have been established in pediatric patients. *Use is supported by a single-arm trial in pediatric patients with relapsed or refractory B-cell precursor ALL. *This study included 70 pediatric patients 1 month to less than 18 years. *Adverse reactions that were observed more frequently in the pediatric population compared to the adult population were anemia (41% vs 18%), thrombocytopenia (21% vs.11%), vomiting (24% vs. 13%), pyrexia (80% vs. 62%), and hypertension (26% vs. 8%). In pediatric patients less than 2 years old (infants), the incidence of neurologic toxicities was not significantly different than for the other age groups, but its manifestations were different; the only event terms reported were agitation, headache, insomnia, somnolence, and irritability. Infants also had an increased incidence of hypokalemia (50%) compared to other pediatric age cohorts (15-20%) or adults (23%). *Information on dosing, adverse reactions, and clinical trial.
|
Labeling
|
B
|
|
|
|
Amgen
|
|
FALSE
|
Antineoplastic
|
09/02/2016
|
Canasa Suppositories
|
mesalamine
|
Mildly to moderately active ulcerative proctitis
|
*Safety and effectiveness in pediatric patients have not been established. *Canasa was evaluated for the treatment of ulcerative proctitis in a 6-week, open-label, single-arm study in 49 patients 5 to 17 years of age. *Adverse reactions were similar to those seen in adult patients. *Information on adverse reactions, and clinical trial. *Postmarketing study.
|
|
|
P
|
|
|
Forest
|
|
FALSE
|
|
09/09/2016
|
Noxafil
|
posaconazole
|
Postmarketing study
|
*In a study of 136 neutropenic pediatric patients 11 months to less than 18 years treated with posaconazole oral suspension, the exposure was attained in approximately 50% of patients instead of the pre-specified 90% of patients. *Postmarketing study.
|
|
|
|
B,P
|
|
Merck
|
|
FALSE
|
Antiviral
|
09/09/2016
|
Q-Pan
|
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted*
|
Prophylaxis of influenza A (H5N1) in children (6 months and older) and adults
|
See Package Insert for new information on biologics
|
|
|
P
|
|
|
GlaxoSmithKline Biologicals
|
|
FALSE
|
Preventive Vaccine
|
09/13/2016
|
CUVITRU
|
Immune Globulin Subcutaneous (Human), 20% Liquid*
|
Indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older
|
See Package Insert for new information on biologics
|
|
|
P
|
|
|
Baxalta US, Inc.
|
|
FALSE
|
|
09/27/2016
|
Avelox
|
moxifloxacin hydrochloride
|
Complicated intra-abdominal infections (cIAI)
|
*Safety and efficacy in pediatric patients for tbe treatment of clAl has not been demonstrated. *Pediatric patients 3 months to <18 years of age (N=451) were enrolled in a single randomized, double blind, active controlled trial in clAl including appendicitis with perforation, abscesses and peritonitis. *Adverse reactions were similar to those observed in adults. *Information on adverse reactions, clinical trial.
|
|
|
|
B,P
|
|
Bayer
|
|
FALSE
|
Antibiotic
|
10/06/2016
|
Pertzye
|
pancrelipase
|
Postmarketing study
|
* Labeling updated to include new dosage strength of 4,000 USP lipase units. * Infants may be given 4,000 lipase units (one capsule) per 120 mL of formula or breastfeeding. Do not mix Pertzye capsule contents directly into formula or breast milk prior to administration. * New dosage form
|
Labeling
|
|
P
|
|
|
Digestive Care, Inc.
|
|
FALSE
|
Pancreatic enzyme
|
10/07/2016
|
Gardasil 9
|
Human Papillomavirus 9-valent Vaccine, Recombinant*
|
To include a 2-dose regimen for individuals 9 through 14 years of age.
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Merck Sharp & Dohme Corp.
|
|
FALSE
|
Preventive Vaccine
|
10/14/2016
|
Varibar Pudding
|
barium sulfate
|
Evaluate the oral and pharyngeal function and morphology in adults and pediatric patients 6 months of age and older
|
* Efficacy in pediatric patients above 6 months of age is based on successful opacification of the pharynx during modified barium swallow examinations. * Safety and dosing recommendations in pediatric patients above 6 months of age are based on clinical experience. * Varibar Pudding is contraindicated in pediatric patients with tracheo-esophageal fistula. * Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions. Pediatric patients with cystic fibrosis or Hirschsprung disease should be monitored for bowel obstruction after use. *Information on dosing. * New drug
|
Labeling
|
|
P
|
|
|
Bracco Diagnostics
|
|
FALSE
|
|
10/18/2016
|
Zemplar
|
paricalcitol
|
Secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 3, 4 and 5 in pediatric patients 10 to 16 years
|
*Safety and effectiveness have been established in pediatric patients 10 to 16 years of age. *Use in this age group is supported by evidence from adequate and well controlled studies in adults with CKD, a 12-week double-blind placebo-controlled randomized multicenter study in 36 pediatric patients 10 to 16 years of age with CKD Stages 3 and 4, and safety data from a 12-week open-label single-arm multicenter study in 13 pediatric patients 10 to 16 years of age with CKD Stage 5 receiving peritoneal dialysis or hemodialysis. *Safety and effectiveness in pediatric patients under the age of 10 years have not been established. *Adverse reactions were similar to those reported in adults. *Information on dosing, pharmacokinetic parameters, and clinical trial. *Postmarketing study
|
|
|
P
|
|
|
AbbVie Inc.
|
|
FALSE
|
|
11/04/2016
|
Selzentry
|
maraviroc
|
Treatment of only CCR5-tropic HIV-1 infection in patients 2 years of age and older weighing at least 10 kg
|
*Expanded the indication from adults to pediatric patients 2 years of age and older weighing at least 10 kg. *Safety, pharmacokinetic profile, and antiviral activity were evaluated in treatment-experienced, CCR5-tropic, HIV-1-infected pediatric patients 2 to less than 18 years weighing at least 10 kg in an open-label, multicenter clinical trial. *The pharmacokinetics, safety, and efficacy in patients younger than 2 years have not been established. *Selzentry is contraindicated in pediatric patients with severe renal impairment or End Stage Renal Disease on regular hemodialysis who are receiving potent CYP3A inhibitors. *There are insufficient data to make dosing recommendations for use in pediatric patients concomitantly receiving noninteracting medications and weighing less than 30 kg or in pediatric patients concomitantly receiving potent CYP3A inducers without a potent CYP3A inhibitor. *The most common adverse reactions in treatment-experienced pediatric patients are vomiting, abdominal pain, diarrhea, nausea, and dizziness. *Information on recommended dosing, Pk parameters and clinical trial. *New oral solution and two lower dose strength tablets. *Postmarketing study
|
Labeling
|
P
|
|
|
|
ViiV Healthcare
|
|
FALSE
|
Antiviral
|
11/04/2016
|
Enbrel
|
etanercept
|
Chronic moderate to severe plaque psoriasis (PsO ) in patient who are candidates for systemic therapy or phototherapy patients ages 4 to 17 years
|
*Expanded the indication from adults to pediatric patients 4 to 17 years. *Enbrel has been studied in 211 pediatric patients with moderate to severe PsO aged 4 to 17 years. * Enbrel has not been studied in children less than 4 years of age with PsO. * Adverse events were similar to those observed in adults. *Information on dosing, PK, adverse reactions, and clinical trial. * New indication.
|
Labeling
|
|
P
|
|
|
Immunex Corporation
|
|
FALSE
|
Immunosuppressant
|
11/11/2016
|
Naftin
|
naftifine hydrochloride
|
Tinea corporis in pediatric patients 2 years and older
|
*Expanded the indication down to pediatric patients 2 years and older; previously approved in pediatric patients 12 years and older. *Safety and effectiveness in the treatment of tinea corporis in pediatric patients less than 2 years of age have not been established. *Adverse reactions were similar to those observed in adults. *Information on adverse reactions, pharmacokinetic parameters, and clinical trials. *Postmarketing study
|
Labeling
|
|
P
|
|
|
Merz Pharmaceuticals
|
|
FALSE
|
Antifungal, topical
|
11/18/2016
|
FluLaval
|
Influenza Virus Vaccine*
|
Active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine in persons aged 6 months and older
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
ID Biomedical Corporation of Quebec
|
|
FALSE
|
Preventive Vaccine
|
11/18/2016
|
FluLaval Quadrivalent
|
Influenza Virus Vaccine*
|
Active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine in persons aged 6 months and older
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
ID Biomedical Corporation of Quebec
|
|
FALSE
|
Preventive Vaccine
|
11/25/2016
|
Renvela
|
sevelamer carbonate
|
Control of serum phosphorus in children 6 years of age and older with chronic kidney disease on dialysis
|
*Expanded the indication from adults to pediatric patients ages 6 years and older. *Renvela has not been studied in pediatric patients below 6 years of age. *Most adverse events that were reported as related, or possibly related, to sevelamer carbonate were gastrointestinal in nature. *Information on starting dose and titration, adverse reactions and clinical trial. *Postmarketing study
|
Labeling
|
|
P
|
|
|
Genzyme
|
|
FALSE
|
Phosphate binder
|
12/14/2016
|
Eucrisa ointment
|
crisaborole
|
Mild to moderate atopic dermatitis in patients 2 years of age and older
|
* Safety and effectiveness have been established in pediatric patients age 2 years and older for topical treatment of mild to moderate atopic dermatitis. * Use in this age group is supported by evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled 28-day trials which included 1,313 pediatric patients 2 years and older. *Safety and effectiveness in pediatric patients below the age of 2 years have not been established. * Information on PK, adverse events in adults and children, and clinical trial. *New drug.
|
Labeling
|
|
P
|
|
|
Anacor Pharmaceuticals, Inc.
|
|
FALSE
|
|
12/16/2016
|
Tresiba
|
insulin degludec
|
Improve glycemic control in type 1 and type 2 diabetes mellitus in pediatric patients 1 year and older
|
*Expanded indication from adults to pediatric patients 1 year and older. *Use in pediatric patients 1 year and older with type 1 and type 2 diabetes mellitus is supported by evidence from an adequate and well-controlled study and a pharmacokinetic study. Use in pediatric patients 1 year and older with type 2 diabetes mellitus is also supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients less than 1 year old. *Adverse reactions similar to those observed in adults. *Information on dosing, PK, and clinical trials. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
Novo Nordisk
|
|
FALSE
|
Antidiabetic
|
12/16/2016
|
Ryzodeg 70/30
|
insulin degludec/insulin aspart
|
Improve glycemic control in type 1 and type 2 diabetes mellitus in pediatric patients 1 year and older
|
*Expanded indication from adults to pediatric patients 1 year and older. *Use in pediatric patients 1 year and older with type 1 and type 2 diabetes mellitus is supported by evidence from an adequate and well-controlled study and a pharmacokinetic study. Use in pediatric patients 1 year and older with type 2 diabetes mellitus is also supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients less than 1 year old. *In pediatric patients 1 year and older with switching from other insulin therapies, start Ryzodeg 70/30 at a reduced dose to minimize the risk of hypoglycemia. *In pediatric patients inject Ryzodeg 70/30 subcutaneously once daily with any main meal. *Not recommended for pediatric patients requiring less than 5 units of Ryzodeg 70/30 daily. *Adverse reactions similar to those observed in adults. *Information on dosing, PK, and clinical trials. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
Novo Nordisk
|
|
FALSE
|
Antidiabetic
|
12/22/2016
|
Lyrica
|
pregabalin
|
Fibromyalgia
|
*Safety and efficacy in pediatric patients have not been established. *A 15-week, placebo-controlled trial was conducted with 107 pediatric patients with fibromyalgia, ages 12 through 17 years . *The primary efficacy endpoint of change from baseline to Week 15 in mean pain intensity showed numerically greater improvement for the pregabalin-treated patients compared to placebo-treated patients, but did not reach statistical significance. *The most frequently observed adverse reactions in the clinical trial included dizziness, nausea, headache, weight increased, and fatigue. The overall safety profile in adolescents was similar to that observed in adults with fibromyalgia. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
PF Prism CV
|
|
FALSE
|
Antidepressant
|
12/22/2016
|
Lumason
|
Sulfur Hexafluoride Lipid-Type A Microspheres
|
Evaluation of suspected or known vesicoureteral reflux in pediatric patients
|
*Effectiveness in pediatric patients has been established for use in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux from two published studies comprising a total of 411 pediatric patients. *Safety of intravesical use of Lumason was based on evaluation of published literature involving use of Lumason in over 6000 pediatric patients. No adverse reactions were reported. *Information on published studies. *New indication.
|
Labeling
|
|
P
|
|
|
Bracco Diagnostics
|
|
FALSE
|
Medical Imaging
|
12/22/2016
|
ADYNOVATE
|
Antihemophilic Factor (Recombinant), PEGylated*
|
Treatment and control of bleeding episodes in adolescents and adults with hemophilia A. Routine prophylaxis to reduce the frequency of bleeding episodes in adolescents and adults with hemophilia A.
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Baxalta US Inc.
|
|
FALSE
|
Antihemophilic Factor
|
01/27/2017
|
ArmonAir RespiClick
|
fluticasone propionate
|
Maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older
|
*Approved for use in 12 years and older. *Safety and effectiveness in pediatric patients below the age of 12 years have not been established. *Inhaled corticosteroids, including fluticasone propionate, may cause a reduction in growth velocity in adolescents. *Information on dosing, and adverse reactions and clinical trials in adults and pediatric patients 12 years and older. *New dosage form.
|
Labeling
|
|
P
|
|
|
Teva
|
|
FALSE
|
Antiasthmatic
|
01/27/2017
|
Stribild
|
elvitegravir, cobicistat, emtricitabine/tenofovir disoproxil fumarate
|
HIV in pediatric patients 12 years of age and older weighing at least 35 kg
|
*Expanded the indication to pediatric patients 12 years of age and older weighing at least 35 kg; previously approved in adults. *The PK, safety, and virologic and immunologic responses were evaluated in 50 treatment-naïve, HIV-1-infected subjects aged 12 to less than 18 years weighing at least 35 kg receiving Stribild through 48 weeks in an open-label trial. The safety and efficacy in these patients was similar to that in antiretroviral treatment-naïve adults. *Safety and effectiveness in pediatric patients less than 12 years of age or weighing less than 35 kg have not been established. *Clinical trials evaluating tenofovir DF in pediatric and adolescent patients were conducted. In HIV-1-infected subjects aged 2 years to less than 18 years, bone effects were similar to those observed in adult subjects and suggest increased bone turnover. Total body BMD gain was less in the tenofovir DF-treated HIV-1-infected pediatric subjects as compared to the control groups. In all pediatric trials, skeletal growth (height) appeared to be unaffected. *Information on clinical trials, adverse reactions, and PK parameters. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
Gilead
|
|
FALSE
|
Antiviral
|
01/27/2017
|
Ofirmev
|
acetaminophen
|
Treatmeny of pain and fever in pediatric patients birth to 2 years
|
Treatment of pain *Efficacy was not demonstrated in pediatric patients younger than 2 years in a double-blind, placebo-controlled study of 198 pediatric patients younger than 2 years. *Pediatric patients less than 2 years of age, including neonates from 28 to 40 weeks gestational age at birth, were randomized to receive opioid plus acetaminophen or opioid plus placebo. No difference in analgesic effect of intravenous acetaminophen, measured by assessment of reduced need for additional opioid treatment for pain control, was observed. Treatment of fever *The safety and effectiveness for the treatment of fever in pediatric patients, including premature neonates born at 32 weeks or greater gestation is supported by adequate and well-controlled studies of Ofirmev in adults, clinical studies in 244 pediatric patients 2 years and older, and safety and pharmacokinetic data from 239 patients younger than 2 years including neonates 32 weeks or greater gestational age. *Information on dosing, clinical trials. *Postmarketing study.
|
Labeling
|
|
|
B,P
|
|
Mallinckrodt
|
07/11/2016
|
FALSE
|
Analgesic; Antipyretic
|
01/27/2017
|
Latuda
|
lurasidone hydrochloride
|
Treatment of schizophrenia in adolescents and irritability associated with autistic disorder in pediatric patients
|
Schizophrenia *Safety and effectiveness for the treatment of schizophrenia in adolescents 13 to 17 years was established in a 6-week, placebo-controlled clinical study in 326 adolescent patients. *In the short-term, placebo-controlled adolescent schizophrenia study, somnolence was reported by 14.5% (31/214) of patients treated with Latuda compared to 7.1% (8/112) of placebo patients. *In the short-term, placebo-controlled, study of schizophrenia in adolescents, the incidence of EPS, excluding events related to akathisia, for Latuda-treated patients was higher in the 40 mg (10%) and the 80 mg (7.7%) treatment groups vs. placebo (3.6%); and the incidence of akathisia-related events for Latuda-treated patients was 8.9% vs. 1.8% for placebo-treated patients. *The most common adverse reactions in adolescent patients treated with Latuda were somnolence, nausea, akathisia, extrapyramidal symptoms (non-akathisia, 40mg only), vomiting, and rhinorrhea/rhinitis (80mg only). Irritability Associated with Autistic Disorder *The effectiveness in pediatric patients for the treatment of irritability associated with autistic disorder has not been established. *Efficacy was not demonstrated in a 6-week study of 149 pediatric patients 6 to 17 years with irritability associated with autistic disorder. *Vomiting occurred at a higher rate than reported in other Latuda studies (4/49 or 8% for 20mg, 14/51 or 27% for 60mg, and 2/49 or 4% for placebo), particularly in children ages 6 to 12 (13 out of 18 patients on Latuda with vomiting). *Information on dosing, metabolic changes, adverse reactions and clinical trials. *Postmarketing study.
|
Labeling
|
|
|
B,P
|
|
Sunovion Pharmaceuticals
|
12/20/2016
|
FALSE
|
Antipsychotic
|
01/27/2017
|
Symbicort Inhalation Aerosol
|
budesonide/formoterol fumarate dihydrate
|
Asthma in pediatric patients 6 to less than 12 years
|
*Expanded indication down to 6 to less than12 years; previously approved down to pediatric patients 12 years and older. * Safety and effectiveness in asthma patients less than 6 years have not been established. *Safety profile in pediatric patients 6 to less than 12 years was similar to that observed in patients 12 years of age and older.*Information on dosing, adverse reactions, and clinical trials. *Postmarketing study.
|
Labeling
|
|
|
B,P
|
|
AstraZeneca
|
01/25/2017
|
FALSE
|
Antiasthmatic
|
01/27/2017
|
AirDuo RespiClick
|
fluticasone propionate/salmeterol
|
"Maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older"
|
*Approved for use in 12 years and older. *Safety and effectiveness in pediatric patients below the age of 12 years have not been established. *Inhaled corticosteroids, including fluticasone propionate, may cause a reduction in growth velocity in adolescents. *Information on dosing, and adverse reactions and clinical trials in adults and pediatric patients 12 years and older. *New dosage form.
|
Labeling
|
|
P
|
|
|
Teva
|
|
|
Antiasthmatic
|
01/28/2017
|
Vyvanse Chewable Tablet
|
lisdexamfetamine
|
Attention Deficit Hyperactivity Disorder in pediatric patients ages 6 to 17 years
|
*New Vyvanse chewable tablets approved. Vyvanse chewable tablets must be chewed thoroughly before swallowing. *Vyvanse capsules can be substituted with Vyvanse chewable tablets on a unit per unit/ mg per mg basis (e.g., 30 mg capsules for 30 mg chewable tablet). *Information on pharmacokinetics. *New formulation.
|
Labeling
|
|
P
|
|
|
Shire
|
|
FALSE
|
CNS Stimulant
|
02/15/2017
|
Spiriva Respimat Inhalation Spray
|
tiotropium bromide
|
Long-term, once-daily, maintenance treatment of asthma in patients 6 through 11 years of age
|
*Expanded indication down to 6 years and older based on three clinical trials in patients 6 to 11 years; previously approved in 12 years and older. *The safety and efficacy have not been established in pediatric patients less than 6 years of age. *The safety of Spiriva Respimat delivered with a valved holding chamber with facemask once daily has been studied in pediatric patients with asthma aged 1 to 5 years who were on background treatment of at least Inhaled Corticosteroid in one placebo-controlled clinical trial of 12 weeks duration. *The adverse reaction profile was similar to that observed in adults and older pediatric patients. *Information on dosing, adverse reactions and clinical trials. *Postmarketing study.
|
Labeling
|
|
|
B,P
|
|
Boehringer Ingelheim
|
|
FALSE
|
Antiasthmatic
|
02/23/2017
|
RotaTeq
|
Rotavirus Vaccine, Live, Oral, Pentavalent*
|
Prevention of rotavirus gastroenteritis caused by types G1, G2, G3, G4, and G9 in infants 6 weeks to 32 weeks of age
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Merck Sharp & Dohme Corp.
|
|
FALSE
|
Preventive Vaccine
|
03/01/2017
|
Liquid E-Z-Paque
|
barium sulfate
|
Use in single contrast radiographic examinations of the esophagus, stomach, and small bowel to visualize the gastrointestinal (GI) tract in adult and pediatric patients
|
*Efficacy in pediatric patients from birth to less than 17 years of age is based on successful opacification of the esophagus, stomach, and small bowel during single contrast radiographic procedures. * Safety and dosing recommendations in pediatric patients are based on clinical experience. * Contraindicated in pediatric patients with tracheo-esophageal fistula. * Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions. Monitor pediatric patients with cystic fibrosis or Hirschsprung disease for bowel obstruction after use. * Information on dosing.
|
Labeling
|
|
P
|
|
|
Bracco Diagnostics
|
|
FALSE
|
Medical Imaging
|
03/01/2017
|
Cerebyx
|
fosphenytoin sodium
|
Treatment of generalized tonic-clonic status epilepticus, for the prevention and treatment of seizures occurring during neurosurgery, and for short-term substitution for oral phenytoin in pediatric patients birth to less than 17 years of age
|
*Approved for use in pediatric patients birth to less than 17 years. *Because rapid intravenous administration of Cerebyx increases the risk of adverse cardiovascular reactions, the rate of administration should not exceed 2 mg PE/kg/min ((or 150 mg PE/min, whichever is slower) in pediatric patients. * Intramuscular administration of Cerebyx should ordinarily not be used in pediatric patients. * Adverse reactions in pediatric patients were similar to those observed in adults. *Information on dosing, adverse reactions, and PK.
|
Labeling
|
|
|
B
|
|
Parke-Davis
|
|
|
Anticonvulsant
|
03/03/2017
|
Rubber Panel T.R.U.E. TEST
|
Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test¿
|
An aid in the diagnosis of allergic contact dermatitis in persons 6 years of age and older whose history suggests sensitivity to one or more of the 5 substances included on the Rubber Panel T.R.U.E. TEST
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
SmartPractice Denmark ApS
|
|
FALSE
|
|
03/14/2017
|
Vigamox Ophthalmic Solution
|
moxifloxacin
|
Bacterial conjunctivitis in pediatric patients less than 1 year of age
|
*Expanded the indication down to pediatric patients less than 1 year; previously approved for 1 year and older. *Information on clinical trial in pediatric patients birth to 31 days.
|
Labeling
|
|
|
B
|
|
Alcon
|
01/10/2003
|
FALSE
|
Antibiotic, topical
|
03/21/2017
|
Zymar Ophthalmic Solution
|
gatifloxacin
|
Bacterial conjunctivitis in pediatric patients less than 1 month of age
|
*Expanded the indication down to pediatric patients less than 1 year; previously approved for 1 year and older. *Information on clinical trial in pediatric patients birth to 31 days.
|
Labeling
|
|
|
B
|
|
Allergan
|
05/19/2009
|
FALSE
|
Antibiotic, topical
|
03/21/2017
|
Ciloxan ophthalmic solution
|
ciprofloxacin
|
Bacterial conjunctivitis in pediatric patients less than 1 month old
|
*Expanded the indication down to pediatric patients less than 1 year; previously approved for 1 year and older. *Information on clinical trial in pediatric patients birth to 31 days.
|
Labeling
|
P
|
|
B
|
|
Alcon
|
01/10/2003
|
FALSE
|
Antibiotic, topical
|
03/29/2017
|
Cubicin Injection
|
daptomycin
|
Complicated skin and skin structure infections (cSSSI) in pediatric patients 1 to 17 years of age
|
*Safety and effectiveness in the treatment of cSSSI has been established in the age groups 1 to 17 years. Use in these age groups is supported by evidence from adequate and well-controlled studies in adults, with additional data from pharmacokinetic studies in pediatric patients, and data from a safety, efficacy and PK study in pediatric patients 1 to 17 years of age with cSSSI. * Safety and effectiveness in pediatric patients below the age of one year have not been established. Avoid use of Cubicin in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems observed in neonatal dogs. * Not indicated in pediatric patients with renal impairment because dosage has not been established in these patients. * The safety profile in pediatric patients was similar to that observed in adult patients. * Information on dosing, administration, adverse reactions, PK, and clinical trial. * Postmarketing study.
|
Labeling
|
|
|
B,P
|
|
Cubist Pharmaceuticals, Inc.
|
|
FALSE
|
Antibiotic
|
03/30/2017
|
Orencia
|
abatacept
|
Treatment of moderately to severely active Polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older
|
*Approved for use in pJIA in pediatric patients 2 years and older as monotherapy or concominatly with methotrexate. *For pJIA, Orencia may be administered as an intraveneous infusion in 6 years and older or a subcutaneous injection in 2 years and older. Intraveneous dosing has not been studied in pediatric patients younger than 6 years of age. *Orencia with intravenous administration has not been studied in patients younger than 6 years of age. *Efficacy of Orencia for subcutaneous injection in children 2 to 17 years of age is based on pharmacokinetic exposure and extrapolation of established efficacy of intravenous Orencia in polyarticular JIA patients and subcutaneous Orencia in patients with RA. *Safety and efficacy of Orencia ClickJect autoinjector for subcutaneous injection have not been studied in patients under 18 years of age. *Safety and efficacy in pediatric patients for uses other than juvenile idiopathic arthritis have not been established. *Adverse reactions were similar to those observed in adults. *Information on adverse reactions, immunogenicity, dosing, clinical trials. *Postmarketing study.
|
Labeling
|
|
|
B,P
|
|
Bristol-Myers Squibb
|
02/17/2017
|
FALSE
|
Anti-inflammatory
|
04/05/2017
|
Visipaque
|
iodixanol 320 mgI/mL
|
"Coronary computed tomography angiography (CCTA) to assist diagnostic evaluation of adults and pediatric patients 12 years and older with suspected coronary artery disease"
|
*Approved for use for CCTA in adults and pediatric patients 12 years and older. *Safety and efficacy have not been established in pediatric patients less than 12 years for CCTA. *Pediatric patients at higher risk of experiencing an adverse reaction during and after administration of any contrast agent may include those with asthma, hypersensitivity to other medication and/or allergens, cyanotic and acyanotic heart disease, congestive heart failure, or a serum creatinine greater than 1.5 mg/dL. Pediatric patients with immature renal function or dehydration may be at increased risk for adverse events due to slower elimination of iodinated contrast agents. *Information on safety, and dosing. *New indication.
|
Labeling
|
|
P
|
|
|
GE HealthCare Inc.
|
|
FALSE
|
Medical imaging
|
04/07/2017
|
Sovaldi
|
sofosbuvir
|
In combination with ribavirin for the treatment of chronic hepatitis C virus genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis in pediatric patients 12 to 17 years of age or weighing at least 35 kg
|
*Expanded the indication from adults to pediatric patients 12 years and older or weighing at least 35 kg. *Sovaldi was evaluated in an open-label clinical trial which included 50 patients 12 years of age and older. *Safety and efficacy have not been established in pediatric patients less than 12 years of age and weighing less than 35 kg with HCV genotype 2 or 3. Safety and efficacy have not been established in pediatric patients with HCV genotype 1 or 4. *Adverse reactions were similar to those observed in adults. *Information on dosing,clinical trial, and PK.
|
Labeling
|
|
P
|
|
|
Gilead Sciences
|
|
FALSE
|
Antiviral
|
04/07/2017
|
Harvoni
|
ledipasvir and sofosbuvir
|
Treatment of chronic hepatitis C virus genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis in pediatric patients 12 years of age and older or weighing at least 35 kg
|
*Expanded the indication from adults to pediatric patients 12 years and older or weighing at least 35 kg. *Safety, pharmacokinetics, and efficacy for treatment of HCV genotype 1 infection in treatment-naïve and treatment-experienced pediatric patients 12 years of age and older without cirrhosis or with compensated cirrhosis have been established in an open-label, multicenter clinical trial. *Safety and efficacy have not been established in pediatric patients less than 12 years and weighing less than 35 kg, in pediatric patients with decompensated cirrhosis, or in pediatric liver transplant recipients. *Adverse reactions were similar to those observed in adults. *Information on dosing, clinical trial, and PK
|
Labeling
|
|
P
|
|
|
Gilead Sciences
|
|
FALSE
|
Antiviral
|
05/17/2017
|
Jevtana
|
cabazitaxel
|
Solid tumors
|
*Safety and effectiveness in pediatric patients have not been established. *Jevtana was evaluated in 39 pediatric patients (ages 3 to 18 years) receiving prophylactic granulocyte - colony stimulating factor. No objective responses were observed in 11 patients with refractory high grade glioma or diffuse intrinsic pontine glioma. One patient had a partial response among the 9 patients with ependymoma. *Infusion-related/hypersensitivity reactions were seen in 10 patients (26%). Three patients experienced serious adverse events of anaphylactic reaction. The incidence of infusion related/hypersensitivity reactions decreased with steroid premedication. *The most frequent treatment-emergent adverse events were similar to those reported in adults. *Information on safety, dosing, PK parameters, and clinical trials.
|
Labeling
|
B
|
|
|
|
Sanofi Aventis
|
05/18/2017
|
FALSE
|
Antineoplastic
|
05/23/2017
|
Sensipar
|
cinacalcet
|
Treatment of secondary HPT in pediatric patients with Chronic Kidney Disease on dialysis
|
*Safety and efficacy for the pediatric population have not been established. *Use for the treatment of secondary HPT in pediatric patients with CKD on dialysis was evaluated in two randomized, controlled studies in 47 pediatric patients aged 6 years to less than 18 years and in one single-arm study in 17 pediatric patients aged 28 days to less than 6 years. *Dosing with Sensipar in pediatric study 1 was stopped because of a fatality in a Sensipar-treated individual who was noted to be severely hypocalcemic at the time of death. The cause of death was multifactorial and a contribution of Sensipar to the death could not be excluded. *Life threatening events and fatal outcomes associated with hypocalcemia have been reported in patients treated with Sensipar, including in pediatric patients. *Pediatric studies did not establish a safe and effective Sensipar dosing regimen for the pediatric population. *Information on safety, and clinical trials.
|
Labeling
|
B
|
|
|
|
Amgen
|
|
FALSE
|
|
05/26/2017
|
Isentress HD
|
raltegravir
|
In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and in pediatric patients weighing at least 40 kg
|
*New 600 mg film coated tablet approved for once daily use. *Isentress HD once daily has not been studied in pediatric patients. However population PK modeling and simulation support the use of 1200 mg (2 x 600 mg) once daily in pediatric patients weighing at least 40 kg. *New dosage form.
|
|
|
P
|
|
|
Merck Sharp & Dohme Corp.
|
|
FALSE
|
Antiviral
|
05/30/2017
|
Zerviate Ophthalmic Solution
|
cetirizine
|
Ocular itching associated with allergic conjunctivitis in patients 2 years of age and older
|
*Safety and effectiveness have been established in pediatric patients two years of age and older. *Use in these pediatric patients is supported by evidence from adequate and well-controlled studies in pediatric and adult patients. *New dosage form.
|
|
|
|
B,P
|
|
Nicox Ophthalmics, Inc.
|
08/29/2016
|
FALSE
|
Antihistamine, topical
|
05/31/2017
|
Rebinyn
|
Coagulation Factor IX (Recombinant), GlycoPEGylated*
|
Approved for use in adults and children with hemophilia B for: (1) On-demand treatment and control of bleeding episodes; (2) Perioperative management of bleeding
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Novo Nordisk
|
|
FALSE
|
|
06/07/2017
|
FIBRYNA
|
Fibrinogen (Human)*
|
Treatment of acute bleeding episodes in adults and adolescents = 12 years of age with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H.
|
|
FALSE
|
|
06/15/2017
|
Calcium Gluconate
|
calcium gluconate
|
Treatment of acute symptomatic hypocalcemia
|
*Safety and effectiveness have been established in pediatric patients for the treatment of acute, symptomatic hypocalcemia. *Pediatric approval is not based on adequate and well-controlled clinical studies. Safety and dosing recommendations in pediatric patients are based on published literature and clinical experience. *Concomitant use of ceftriaxone and calcium gluconate Injection is contraindicated in neonates (28 days or younger) due to reports of fatal outcomes associated with the presence of lung and kidney ceftriaxone-calcium precipitates. In patients older than 28 days, ceftriaxone and calcium gluconate Injection may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid. *This product contains up to 400 mcg/L aluminum which may be toxic, particularly for premature neonates due to immature renal function. Parenteral administration of aluminum greater than 4 to 5 mcg/kg/day is associated with central nervous system and bone toxicity. *New drug.
|
Labeling
|
|
P
|
|
|
Fresenius Kabi USA, LLC
|
|
FALSE
|
|
06/19/2017
|
Cotempla XR-ODT
|
methylphenidate
|
Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
|
*Safety and effectiveness have been established in pediatric patients 6 to 17 years in one adequate and well-controlled study in pediatric patients 6 to 12 years, pharmacokinetic data in adolescents, and safety information from other methylphenidate-containing products. *Safety and effectiveness in pediatric patients below 6 years of age have not been established. *The long-term efficacy of methylphenidate in pediatric patients has not been established. *Growth should be monitored during treatment with stimulants. *Information on dosing, adverse reactions, and clinical trial. *New dosage form.
|
Labeling
|
|
P
|
|
|
Neos Therapeutics, Inc.
|
|
FALSE
|
CNS Stimulant
|
06/20/2017
|
Mydayis
|
mixed salts of a single-entity amphetamine
|
Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
|
*Safety and effectiveness in pediatric patients with ADHD ages 13 to 17 years have been established in two placebo-controlled clinical studies. *Safety and effectiveness have not been established in pediatric patients ages 12 years and younger. *In clinical trials, pediatric patients 6 to 12 years of age experienced higher rates of adverse reactions in some cases compared to patients 13 years and older, including higher rates of insomnia (30% versus 8%) and appetite decreased (43% versus 22%). *Amphetamine systemic exposures (both d- and l-) in patients 6 to 12 years following a single dose were higher than those observed in adults at the same dose. *Information on PK parameters, adverse reactions and clinical trials. *New dosage form.
|
Labeling
|
|
P
|
|
|
Shire
|
|
FALSE
|
CNS Stimulant
|
06/22/2017
|
Simponi
|
golimumab
|
Active polyarticular juvenile idiopathic arthritis
|
*Effectiveness in pediatric patients less than 18 years of age has not been established. *Safety and efficacy were evaluated in a multicenter, placebo-controlled, double-blind, randomized-withdrawal, parallel group study in 173 children 2 to 17 years of age with active polyarticular juvenile idiopathic arthritis (pJIA) despite treatment with MTX for at least 3 months. *Adverse reactions were similar to those observed in adults. *Information dosing, and clinical trial. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
Janssen Biotech, Inc.
|
|
FALSE
|
Anti-inflammatory
|
07/06/2017
|
Vimovo
|
naproxen/esomeprazole magnesium
|
Juvenile idiopathic arthritis (JIA) in adolescent patients 12 years of age and older weighing at least 38 kg
|
*Safety and effectiveness have been established in adolescent patients 12 years and older weighing at least 38 kg for the symptomatic relief of JIA and to decrease the risk of developing naproxen-associated gastric ulcers. *Use in this age group is based on extrapolation of adequate and well-controlled studies in adults and supported by a 6 month safety study including pharmacokinetic assessment of naproxen and esomeprazole magnesium in 36 adolescent patients with JIA. *The safety profile in adolescent patients with JIA was similar to adults with RA. *Safety and effectiveness in pediatric patients less than 12 years or less than 38 kg with JIA have not been established. *Information on recommended dosing, and PK. *New indication.
|
Labeling
|
|
P
|
|
|
Horizon Pharma Inc.
|
|
FALSE
|
Anti-inflammatory
|
07/26/2017
|
Fycompa
|
perampanel
|
Monotherapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older
|
*Expanded the indication to include use as monotherapy for the treatment POS in patients with epilepsy aged 12 years and older; previously approved for use as adjunctive therapy. *New indication.
|
Labeling
|
|
P
|
|
|
Eisai Inc.
|
|
|
Anticonvulsant
|
08/25/2017
|
Dotarem
|
gadoterate meglumine
|
Contrast agent for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity
|
*Expanded indication down to term neonates; previously approved for use in 2 years and older. *A non-randomized study with 28 pediatric patients under 2 years who were referred for contrast MRI of the CNS supported extrapolation of CNS efficacy findings from adults and older children. *Safety has not been established in preterm neonates. *No cases of Nephrogenic Systemic Fibrosis associated with Dotarem or any other gadolinium-based contrast agents have been identified in pediatric patients age 6 years and younger. *Information on dosing, PK parameters, adverse reactions in pediatric patients, and clinical trial.
|
Labeling
|
|
P
|
|
|
Guerbet
|
|
FALSE
|
Medical imaging
|
08/27/2017
|
T.R.U.E TEST
|
Thin-Layer Rapid Use Epicutaneous Patch Test*
|
To include final report for Protocol SP 12 7NEW 401: Clinical Evaluation of T.R.U.E. TEST Panel 3.2 in Children and Adolescents (PREA II).
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
SmartPractice Denmark ApS
|
|
FALSE
|
|
08/31/2017
|
Afluria Quadrivalent
|
Influenza Vaccine*
|
Active immunization for the prevention of influenza disease caused by virus types A and B contained in the vaccine in pediatric patients 5 years of age and older
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Seqirus, Inc.
|
|
FALSE
|
Preventive Vaccine
|
09/01/2017
|
Cubicin Injection
|
daptomycin
|
Staphylococcus aureus bacteremia
|
*Safety and effectiveness in the treatment staphylococcus. aureus bloodstream infections (bacteremia) have been established in the age groups 1 to 17 years of age. *Use in these age groups is supported by evidence from adequate and well-controlled studies in adults, with additional data from pharmacokinetic studies in pediatric patients, and from safety, efficacy and PK studies in pediatric patients with cSSSI and S. aureus bloodstream infections. *Safety and effectiveness in pediatric patients below the age of one year have not been established. *Cubicin has not been studied in pediatric patients with other bacterial infections. *Information on dosing, PK parameters, adverse reactions, and clinical trial.
|
Labeling
|
|
|
B,P
|
|
Cubist Pharmaceuticals, Inc.
|
|
FALSE
|
Antibiotic
|
09/13/2017
|
Aptiom
|
eslicarbazepine acetate
|
Treatment of partial-onset seizures
|
*Safety and effectiveness have been established in the age groups 4 to 17 years. *Use in these age groups is supported by evidence from adequate and well-controlled studies in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data from clinical studies in 393 pediatric patients 4 to 17 years of age. *Safety and effectiveness in pediatric patients below the age of 4 years have not been established. *Information on dosing, adverse reactions and PK parameters. *Postmarketing study
|
Labeling
|
|
|
B,P
|
|
Sunovion Pharmaceutical Inc.
|
|
FALSE
|
Anticonvulsant
|
09/15/2017
|
Adzenys ER
|
amphetamine
|
Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older
|
*Safety and effectiveness have been established in pediatric patients with ADHD ages 6 to 17 years of age in three adequate and well-controlled clinical trials of up to 4 weeks in duration. *Safety and efficacy in pediatric patients younger than 6 years of age with ADHD have not been established. *Growth should be monitored during treatment with stimulants, including ADZENYS ER, and children who are not growing or gaining weight as expected may need to have their treatment interrupted. * Information on dosing, adverse reactions, PK parameters, and clinical trials.
|
Labeling
|
|
P
|
|
|
Neos Therapeutics, Inc.
|
|
FALSE
|
CNS Stimulant
|
09/20/2017
|
Rapivab
|
peramivir
|
Treatment of acute uncomplicated influenza in patients 2 years and older
|
*Expanded the patient population to include the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than two days based on clinical studies of 110 adolescent and pediatric patients. *Information on s dosing, adverse reactions, PK parameters, and clinical trials.
|
Labeling
|
|
P
|
|
|
BioCryst Pharmaceuticals, Inc.
|
|
FALSE
|
|
09/25/2017
|
Genvoya
|
elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide
|
elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide
|
*Approved for use in pediatric patients weighing at least 25 kg; previously approved in 12 to less than 18 years and weighing at least 35 kg. *Use in pediatric patients weighing at least 25 kg is supported by studies in adults and by an open-label trial in virologically-suppressed pediatric patients 6 to less than 12 years and weighing at least 25 kg, in which subjects were switched from their antiretroviral regimen to Genvoya. *Safety and effectiveness in pediatric patients less than 25 kg have not been established. *Safety profile in pediatric patients who received treatment was similar to that in adults. *Information on dosing, adverse reactions, and clinical trial.*Postmarketing study.
|
|
|
|
B,P
|
|
Gilead Sciences
|
|
FALSE
|
Antviral
|
09/28/2017
|
Descovy
|
emtricitabine and tenofovir alafenamide
|
HIV-1 infected, virologically suppressed children weighing at least 25 kg
|
*Safety and effectiveness of Descovy, in combination with other antiretroviral agents, for the treatment of HIV-1 infection was established in pediatric patients with body weight greater than or equal to 25 kg; previously approved in pediatric patients 12 to less than 18 years weighing at least 35 kg *Safety and effectiveness of Descovy coadminstered with an HIV-1 protease inhibitor that is administered with either ritonavir or cobicistat have not been established in pediatric subjects weighing less than 35 kg *Not recommended for patients weighing less than 25 kg. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study
|
Labeling
|
|
P
|
|
|
Gilead
|
|
FALSE
|
Antiviral
|
10/13/2017
|
Stelara
|
ustekinumab
|
Psoriasis treatment of adolescent patients ages 12-17 years
|
*Safety and effectiveness of have been established in pediatric subjects 12 to 17 years old with moderate to severe plaque psoriasis. Use of in this age group is supported by evidence from a multicenter, randomized, 60-week trial that included a 12-week, double-blind, placebo-controlled, parallel-group portion, in 110 pediatric subjects 12 years and older. *Safety and effectiveness for pediatric patients less than 12 years of age have not been established. *Adverse reactions observed in 12-17 years were similar to adults. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study
|
|
|
P
|
|
|
Janssen
|
|
FALSE
|
Monoclonal antibody
|
10/13/2017
|
Pegays
|
peginterferon alfa-2a
|
Treatment of non-cirrhotic pediatric patients 3 years of age and older with HBeAg-positive Chronic Hepatitis B virus infection
|
*Use for the treatment of pediatric patients 3 to 17 years of age with CHB is based on one clinical trial in 161 previously untreated CHB subjects 3 to 17 years of age of whom 111 were assigned to treatment with PEGASYS. *PEGASYS has not been studied in pediatric CHB patients with liver cirrhosis and the safety and efficacy in pediatric patients with CHB below the age of 3 years have not been established. *Growth inhibition was observed in CHB pediatric patients 3 to 17 years of age during therapy with PEGASYS lasting up to 48 weeks. *Adverse reactions observed in 3-17 years were similar to adults. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study
|
Labeling
|
|
P
|
|
|
Hoffman- LaRoche
|
|
FALSE
|
Antiviral
|
10/13/2017
|
Butrans transdermal system
|
buprenorphine
|
Treatment of moderate-to severe chronic pain requiring continuous, around-the clock opioid treatment for an extended period of time
|
*Safety and efficacy in patients under 18 years of age have not been established. *Butrans has been evaluated in an open-label clinical trial in pediatric patients. However, definitive conclusions are not possible because of the small sample size. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
Purdue
|
|
FALSE
|
Analgesic
|
11/03/2017
|
Vimpat
|
lacosamide
|
Treatment of partial-onset seizures to patients 4 years of age and older
|
*Expanded the use of Vimpat tablets and oral solution for the treatment of partial-onset seizures to patients 4 years of age and older. *Use in this age group is supported by evidence from adequate and well-controlled studies in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 328 pediatric patients 4 to less than 17 years of age. *Safety and effectiveness in pediatric patients below the age of 4 years have not been established. *Safety of Vimpat injection in pediatric patients has not been established. *In pediatric patients 4 years to less than 17 years of age, the recommended dosing regimen is based on body weight and is only recommended to be administered orally. *Adverse reactions were similar to those observed in adults. *Information on PK parameters, dosing, adverse reactions. *Postmarketing study.
|
|
|
P
|
|
|
UCB, Inc.
|
|
TRUE
|
Anticonvulsant
|
11/14/2017
|
Tekturna
|
aliskiren
|
Treatment of hypertension in adults and children 6 years of age and older
|
*Approved for use in adults and children 6 years and older. *Tekturna was evaluated in two randomized, double-blind clinical studies in pediatric patients 6 to 17 years of age. *Tekturna is contraindicated in children less than 2 years of age. Tekturna should not be used in children 2 to less than 6 years or in children who weigh less than 20 kg. *Preclinical studies indicate a potential for substantial increase in exposure to aliskiren in pediatric patients. *Information on administration of oral pellets. Do not chew or crush the contents of the capsules. *Adverse reactions were similar to those observed in adults. *Information on dosing, PK, and clinical trial. *Postmarketing study.
|
|
|
|
B, P
|
|
Noden Pharma DAC
|
|
FALSE
|
Antihypertensive
|
11/14/2017
|
Fasenra
|
benralizumab
|
Add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype
|
*Indicated in pediatric patients 12 years and older. *There were 108 adolescents aged 12 to 17 with asthma enrolled in the two Phase 3 exacerbation trials. *Safety and efficacy in patients younger than 12 years of age has not been established. *Adverse reactions were similar to those observed in adults. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *New drug.
|
|
|
P
|
|
|
AstraZeneca
|
|
FALSE
|
Antiasthmatic
|
11/21/2017
|
Triumeq
|
abacavir, dolutegravir, and lamivudine
|
Treatment of HIV-1 infection in patients weighing at least 40 kg
|
*Clinical data supporting use of Triumeq in HIV-1 infected pediatric patients weighing at least 40 kg is derived from previously conducted pediatric trials using the individual components of Triumeq. *Triumeq is a fixed-dose combination tablet which cannot be adjusted for patients weighing less than 40 kg. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
ViiV Healthcare
|
|
FALSE
|
Antiviral
|
11/22/2017
|
Isentress oral suspension
|
raltegravir
|
HIV exposed neonates ages 0-4 weeks and weighing at least 2 kg
|
*Safety and pharmacokinetics of Isentress oral suspension were evaluated in 42 full-term HIV-1 exposed neonates at high risk of acquiring HIV-1 infection in a Phase 1, open-label, multicenter clinical study. *Not recommended in pre-term neonates or in pediatric patients weighing less than 2 kg. *Safety profile was similar to that observed in adults. *Postmarketing study.
|
|
|
|
B, P
|
|
Merck Sharp & Dohme Corp.
|
08/14/2017
|
FALSE
|
Antiviral
|
12/06/2017
|
Jakafi
|
ruxolitinib
|
Relapsed or refractory solid tumors, leukemias or myeloproliferative neoplasms
|
*The safety and effectiveness of Jakafi in pediatric patients have not been established. *Jakafi was evaluated in a single-arm, dose-escalation study in 27 pediatric patients with relapsed or refractory solid tumors and 20 with leukemias or myeloproliferative neoplasms. *A protocol-defined maximal tolerated dose was not observed, but since few patients were treated for multiple cycles, tolerability with continued use was not assessed adequately to establish a recommended Phase 2 dose. *The safety profile in children was similar to that observed in adults. *Information on dosing, and clinical trial.
|
Labeling
|
B
|
|
|
|
Incyte Corporation
|
|
FALSE
|
Hematology
|
12/08/2017
|
Omidria intraocular solution
|
phenylephrine and ketorolac
|
Prevention of intraoperative miosis and reduction of postoperative pain in patients who have undergone cataract surgery
|
*Safety and effectiveness have been established in the pediatric population from neonates to adolescents (birth to younger than 17 years). * Use in this population is supported by evidence from adequate and well-controlled studies of Omidria in adults with additional data from a single active-controlled safety study in pediatric patients up to 3 years old. *The safety profile in children was similar to that observed in adults. *Information on adverse reactions and clinical trials.
|
Labeling
|
|
P
|
|
|
Omeros Corporation
|
|
FALSE
|
Analgesic, topical
|
12/11/2017
|
Xepi
|
ozenoxacin
|
Impetigo in adults, adolescents and children 2 months and older
|
*Safety and effectiveness in the treatment of impetigo have been established in pediatric patients 2 months to 17 years of age. *Use in pediatric patients 2 months to 17 years of age is supported by evidence from adequate and well-controlled studies in which 251 pediatric patients received at least one dose of Xepi. *Safety and effectiveness in pediatric patients younger than 2 months of age have not been established. *Information on adverse reactions and clinical trials.
|
Labeling
|
|
P
|
|
|
Ferrer Internacional S.A.
|
|
FALSE
|
Antibiotic, topical
|
12/22/2017
|
Lumify Ophthalmic Solution
|
brimonidine tartrate
|
Relief of redness of the eye due to minor eye irritations
|
* Approved for use in adults and pediatric patients 5 years and older. *New formulation.
|
Labeling
|
|
P
|
|
|
Bausch and Lomb
|
|
FALSE
|
Ophthalmologic hypotensive
|
12/22/2017
|
Procysbi
|
cysteamine bitartrate
|
Treatment-naïve nephropathic cystinosis patients 1 year and older
|
*Expanded the indication to patients age 1 year and older; previously approved in 2 years and older. * Safety and effectiveness in pediatric patients under 1 years of age have not been established. *Adverse reactions in pediatric patients were similar to those in adults. *Information on dosing, PK parameters, and clinical trial.
|
|
|
P
|
|
|
Horizon Pharma
|
12/12/2017
|
FALSE
|
|
12/26/2017
|
Draximage DTPA
|
Technetium Tc99m Pentetate
|
Lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients when administered by nebulizer for inhalation and for renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate
|
*Indicated in pediatric patients ages birth to less than 17 years of age. *Pediatric use is supported by evidence from controlled studies in adults and dosing and safety are based on clinical experience. *The radiation risk of Technetium Tc 99m pentetate is greater in pediatric patients than adults. *New route of administration and new indication.
|
|
|
P
|
|
|
Jubilant DraxImage, Inc.
|
|
TRUE
|
Medical imaging
|
01/11/2018
|
Fluarix Quadrivalent
|
Influenza Vaccine*
|
For active immunization of persons 6 months and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline Biologicals
|
|
FALSE
|
Preventive Vaccine
|
02/05/2018
|
Symfi Lo
|
efavirenz, lamivudine and tenofovir disoproxil fumarate
|
HIV-1 infection in adult and pediatric patients weighing at least 35 kg
|
*Safety and effectiveness of Symfi Lo as a fixed-dose tablet in pediatric patients infected with HIV-1 and weighing at least 35 kg have been established based on clinical studies using the individual components. *New dosage form.
|
Labeling
|
|
P
|
|
|
Mylan
|
|
FALSE
|
Antiviral
|
02/06/2018
|
Pristiq
|
desvenlafaxine
|
Major Depressive Disorder (MDD)
|
*Safety and effectiveness have not been established in pediatric patients for the treatment of MDD. *Efficacy was not demonstrated in two adequate and well controlled, 8-week, randomized, double-blind, placebo-controlled, parallel group studies conducted in 587 patients 7 to 17 years for the treatment of MDD. *Antidepressants, such as Pristiq, increase the risk of suicidal thoughts and behaviors in pediatric patients. *Pristiq was associated with a decrease in body weight in placebo-controlled trials in pediatric patients with MDD. The incidence of weight loss was 22%, 14%, and 7% for patients treated with low dose Pristiq, high dose Pristiq, and placebo, respectively. *The risks associated with longer term Pristiq use were assessed in 6-month, open-label extension studies in pediatric patients 7 to 17 years with MDD. *Postmarketing study.
|
Labeling
|
|
|
B,P
|
|
Wyeth
|
|
FALSE
|
Antidepressant
|
02/15/2018
|
Cialis
|
tadalafil
|
Duchenne muscular dystrophy
|
*Not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 18 years have not been established. *A randomized, double-blind, placebo-controlled trial in pediatric patients 7 to 14 years with Duchenne muscular dystrophy failed to demonstrate any benefit of treatment on a range of assessments of muscle strength and performance.
|
Labeling
|
B
|
|
|
|
Eli Lilly
|
|
FALSE
|
Peripheral Vasodilator
|
02/20/2018
|
Luzu cream
|
luliconazole
|
Tinea pedis and tinea cruris
|
*Safety and effectiveness in pediatric patients 12 to <18 years with tinea pedis and tinea cruris have been established by evidence from well-controlled trials in adult and pediatric patients and a pharmacokinetic study in pediatric patients. *Safety and effectiveness in pediatric patients 2 to <18 years of age with tinea corporis have been established by evidence from a well-controlled trial in pediatric patients. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
Medicis
|
|
FALSE
|
Antifungal, topical
|
02/28/2018
|
Cimduo
|
lamivudine and tenofovir disoproxil fumarate
|
Treatment of HIV-1 infection in adult and pediatric patients weighing at least 35 kg
|
*Safety and effectiveness as a fixed-dose tablet in pediatric patients infected with HIV-1 and weighing at least 35 kg have been established based on clinical studies using the individual components. *Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue CIMDUO as clinically appropriate. *New drug.
|
Labeling
|
|
P
|
|
|
Mylan
|
|
FALSE
|
Antiviral
|
03/02/2018
|
Otiprio Otic Suspension
|
ciprofloxacin
|
Treatment of acute otitis externa in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus
|
*Safety and effectiveness for the treatment of acute otitis externa was established in 67 pediatric patients (3 through 17 years of age) who participated in the Phase 3 trial; 57% of patients were 3 through 11 years of age and 43% of patients were 12 through 17 years of age. *Safety and effectiveness in infants below 6 months of age have not been established. *The adverse reactions in pediatric patients were similar to those observed in adults. *Information on clinical trial. *New indication.
|
|
|
P
|
|
|
Otonomy, Inc.
|
|
FALSE
|
Antibiotic, topical
|
03/05/2018
|
Latuda
|
lurasidone hydrochloride
|
Treatment of children and adolescents with major depressive episodes associated with bipolar I disorder
|
*Safety and effectiveness for the treatment of bipolar depression in pediatric patients 10 to 17 years was established in a 6-week, placebo-controlled clinical study in 347 pediatric patients. *Safety and effectiveness have not been established in pediatric patients less than 10 years of age with bipolar depression. *In the 6-week, placebo-controlled bipolar depression study in pediatric patients 10 to 17 years, somnolence was reported by 11.4% (20/175) of patients treated with Latuda compared to 5.8% (10/172) of placebo treated patients. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study.
|
|
|
P
|
|
|
Sunovion Pharmaceuticals
|
|
FALSE
|
Antipsychotic
|
03/22/2018
|
Symfi
|
efavirenz, lamivudine and tenofovir disoproxil fumarate
|
Treatment of HIV-1 infection in adult and pediatric patients weighing at least 40 kg
|
*Safety and effectiveness of Symfi as a fixed-dose tablet in pediatric patients infected with HIV-1 and weighing at least 40 kg have been established based on clinical studies using the individual components (efavirenz, lamivudine, and tenofovir disoproxil fumarate). *New drug.
|
|
|
P
|
|
|
Mylan
|
|
FALSE
|
Antiviral
|
04/03/2018
|
Emend Injection
|
fosaprepitant
|
Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) in pediatric patients 6 months and older
|
*Safety and effectiveness of a single dose regimen of Emend for injection and a 3-day IV/oral/oral Emend regimen have been established in pediatric patients 6 months to 17 years. *Use in this age group is supported by evidence from adequate and well-controlled studies of Emend for injection in adults, with additional safety, efficacy and pharmacokinetic data in pediatric patients 6 months to 17 years. Efficacy was also supported by data from an adequate and well-controlled study of a 3-day oral aprepitant regimen in pediatric patients 6 months to 17 years. *Safety and effectiveness of EMEND for the prevention of nausea and vomiting associated with HEC or MEC have not been established in patients less than 6 months of age. *Safety of Emend for injection administered on consecutive days has not been established in pediatric patients 6 months to 17 years for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of HEC and MEC. *Adverse reactions were similar to those observed in adults. *Information on dosing, PK parameters, adverse reactions and clinical trials. *Postmarketing study.
|
Labeling
|
|
|
B,P
|
|
Merck Sharp & Dohme
|
03/23/2018
|
FALSE
|
Antiemetic
|
04/30/2018
|
Amitiza
|
lubiprostone
|
Pediatric Functional Constipation (PFC)
|
*Safety and effectiveness have not been established in pediatric patients less than 6 years. *Effectiveness has not been established in pediatric patients 6 years and older. Efficacy was not demonstrated for the treatment of PFC in a 12 week, randomized, double-blind, placebo controlled trial conducted in 606 patients 6 to 17 years with PFC comparing Amitiza to placebo. *Adverse reactions were similar to those reported in adults. *Information on clinical trial. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
Sucampo Pharma Americas, LLC
|
|
FALSE
|
|
05/03/2018
|
Lyrica
|
pregabalin
|
Adjunctive therapy in the treatment of partial onset seizures (POS) in pediatric patients 4 years to 16 years of age
|
*Safety and effectiveness as adjunctive treatment for POS in pediatric patients 4 to less than 17 years of age have been established in a 12-week, double-blind, placebo-controlled trial (n = 295). *Safety and effectiveness in patients less than 4 years of age have not been established. *In the trial in pediatric patients for the treatment of partial onset seizures, somnolence was experienced by 21% of Lyrica-treated patients compared to 14% of placebo-treated patients, and occurred more frequently at higher doses. *The most common adverse reactions with Lyrica in the study were somnolence, weight increased, and increased appetite. *Information on dosing, adverse reactions, PK parameters, and clinical trial. *Postmarketing study.
|
|
|
|
B,P
|
|
PF PRISM CV
|
|
FALSE
|
Anticonvulsant
|
05/10/2018
|
Briviact
|
brivaracetam
|
Treatment of partial onset seizures (POS) to include patients 4 years to less than 16 years of age
|
*Safety and effectiveness of Briviact tablets and oral solution have been established in pediatric patients 4 years to less than 16 years. *Use in these age groups is supported by evidence from adequate and well-controlled studies of Briviact in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 149 pediatric patients 4 years to less than 16 years. *Safety and effectiveness in pediatric patients below the age of 4 years have not been established. *Safety of Briviact injection in pediatric patients has not been established. *Adverse reactions, including psychiatric adverse reactions, were observed in open-label pediatric trials and were generally similar to those observed in adults. *Information on dosing, dosing in pediatric patients with hepatic impairment, PK parameters, adverse reactions, and clinical trial. *Postmarketing study.
|
|
|
P
|
|
|
UCB, Inc.
|
|
FALSE
|
Anticonvulsant
|
05/11/2018
|
Gilenya
|
fingolimod
|
Treatment of relapsing forms of multiple sclerosis to include pediatric patients 10 years of age and above
|
*Safety and effectiveness for the treatment of relapsing forms of multiple sclerosis in pediatric patients 10 to less than 18 years were established in one randomized, double-blind clinical study in 215 patients. *Safety and effectiveness in pediatric patients below the age of 10 years have not been established. *Safety in pediatric patients was similar to that observed in adult patients. *In the pediatric study, cases of seizures were reported in 5.6% of Gilenya treated patients and 0.9% of interferon beta-1a treated patients. *It is recommended that pediatric patients if possible, complete all immunizations in accordance with current immunization guidelines prior to initiating Gilenya therapy. *Information on dosing, dosing in pediatric patients with renal impairment, PK parameters, adverse reactions, and clinical trial. *Postmarking study.
|
Labeling
|
|
|
B,P
|
|
Novartis
|
04/16/2018
|
FALSE
|
|
05/11/2018
|
Actemra
|
tocilizumab
|
Treatment of polyarticular juvenile idiopathic arthritis (PJIA) and Systemic Juvenile Idiopathic Arthritis (SJIA)
|
*PJIA - Subcutaneous Use: Actemra by subcutaneous use is indicated for the treatment of pediatric patients with active PJIA in patients 2 years of age and older. *Safety and effectiveness in pediatric patients below the age of 2 years have not been established. *Subcutaneous administration has not been studied in SJIA pediatric patients. *SJIA – Intravenous Use: A multi-center, open-label, single arm study to evaluate the PK, safety and exploratory PD and efficacy of Actemra over 12-weeks in SJIA patients (N=11) under 2 years of age was conducted. *The primary PK endpoints at steady-state in this study were within the ranges of these parameters observed in patients with SJIA aged 2 to 17 years. *Safety and immunogenicity of Actemra for patients with SJIA under 2 years of age was assessed descriptively. *SAEs, AEs leading to discontinuation, and infectious AEs were reported by 27.3%, 36.4%, and 81.8% of patients. Six patients (54.5%) experienced hypersensitivity reactions. There were no cases of macrophage activation syndrome (MAS) based on the protocol-specified criteria, but 2 cases of suspected MAS based on Ravelli criteria. *Information on PK parameters, adverse reactions and clinical trial. *Postmarketing study.
|
Labeling
|
|
|
B,P
|
|
Genentech, Inc.
|
|
FALSE
|
|
05/17/2018
|
Arnuity Ellipta
|
fluticasone furoate
|
Maintenance treatment of asthma in pediatric patients ages 5 through 11 years
|
*Safety and efficacy of in pediatric patients with asthma aged 5 to 11 years have been established in 3 clinical trials. *In those trials, 234 subjects were administered Arnuity Ellipta 50 mcg once daily. Patients aged 5 to 11 years demonstrated safety and efficacy results similar to those observed in subjects aged 12 years and older. *Safety and efficacy have not been established in pediatric patients aged younger than 5 years. *Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to children and adolescents. *Information on dosing, adverse reactions, PK parameters, and clinical trials.
|
Labeling
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE
|
Antiasthmatic
|
06/07/2018
|
Mircera
|
Methoxy Polyethylene Glycol-Epoetin Beta
|
Anemia associated with chronic kidney disease (CKD) in pediatric patients 5 to 17 years of age on hemodialysis who are converting from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA
|
*Safety and effectiveness of Mircera for the treatment of anemia due to CKD have been established in pediatric patients 5 to 17 years on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA. *The use of Mircera in this pediatric age group is supported by evidence from adequate and well-controlled studies of Mircera in adults and a dose-finding study in 64 pediatric patients 5 to 17 years. *Safety and effectiveness of Mircera have not been established in patients less than 5 years of age. *The safety and effectiveness of Mircera have not been established in pediatric patients of any age for subcutaneous administration; for treatment of anemia in patients with CKD on peritoneal dialysis; for treatment of anemia in patients with CKD who are not yet on dialysis; and for patients whose hemoglobin level has not been previously stabilized by treatment with an ESA. *Administer Mircera only intravenously in pediatric patients. *The adverse reaction profile was similar to those observed in adults. *Information on dosing, adverse reactions, PK parameters and clinical trial. *New indication.
|
Labeling
|
|
P
|
|
|
Vifor International AG
|
|
FALSE
|
Hematopoietic
|
06/15/2018
|
LymePak
|
doxycycline hyclate
|
Treatment of early Lyme disease due to Borrelia burgdorferi in adults and pediatric patients 8 years of age and older weighing 45 kg and above
|
*Safety and efficacy have been established in pediatric patients 8 years and older, weighing 45 kg and greater. *Because of the effects of the tetracycline-class of drugs on tooth development, bone development, and growth, use of LymePak in pediatric patients younger than 8 years of age, weighing less than 45 kg is not recommended. *New indication.
|
Labeling
|
|
P
|
|
|
Chartwell
|
|
FALSE
|
Antibiotic
|
06/28/2018
|
Qbrexza cloth
|
glycopyrronium
|
Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older
|
*Safety, effectiveness and pharmacokinetics of Qbrexza have been established in pediatric patients age 9 years and older. *Use in this age group is supported by evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled 4-week trials which included 34 pediatric subjects 9 years and older. *Safety and effectiveness have not been established in pediatric patients less than 9 years of age. *Information on dosing, adverse reactions, clinical trials. *New dosage form.
|
Labeling
|
|
P
|
|
|
Dermira, Inc.
|
|
FALSE
|
|
06/29/2018
|
Yondelis injection
|
trabectedin
|
Pediatric histotypes of sarcoma
|
*Safety and effectiveness in pediatric patients have not been established. *Safety (n=61) and efficacy (n=58) were assessed across five open-label studies in pediatric patients (aged 2 to less than 17 years) with pediatric histotypes of sarcoma. *No new safety signals were observed in pediatric patients across these studies. *Pharmacokinetic parameters in 17 pediatric patients (aged 3 to 17 years) were within the range of values previously observed in adults given the same dose per body surface area.
|
|
B
|
|
|
|
Janssen
|
|
FALSE
|
Antineoplastic
|
07/16/2018
|
Intelence
|
etravirine
|
Treatment of HIV-1 infection in patients 2 years to less than 6 years of age weighing at least 10 kg
|
*Expanded the patient population to include pediatric patients 2 years to less than 6 years weighing at least 10 kg; previously approved in pediatric patients 6 years and older. *Use in pediatric patients 2 years to less than 6 years of age is supported by evidence from adequate and well-controlled studies in adults with additional data from a study in 20 pediatric patients 2 years to less than 6 years. *Treatment is not recommended in pediatric patients less than 2 years. *The pharmacokinetics and dose of etravirine in pediatric patients less than 2 years have not been established. *Safety was similar to that observed in adults. *Information on adverse drug reactions, pediatric trial. *Postmarketing study.
|
Labeling
|
|
|
B,P
|
|
Janssen
|
|
FALSE
|
Antiviral
|
07/20/2018
|
Lotemax
|
loteprednol etabonate ophthalmic gel
|
Treatment of postoperative inflammation and pain following ocular surgery
|
*Safety and effectiveness have been established in the pediatric population. *Use in this population is supported by evidence from adequate and well-controlled trials of Lotemax in adults with additional data from a safety and efficacy trial in pediatric patients from birth to 11 years. *Information on clinical study. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
Bausch and Lomb
|
|
FALSE
|
Anti-inflammatory, topical
|
07/30/2018
|
Kerydin topical solution
|
tavaborole
|
Topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes
|
*Safety and efficacy were established in patients 6 years of age and older. *Use in these age groups is supported by evidence from adequate and well-controlled studies of Kerydin in adults with additional data from an open-label pharmacokinetics study of tavaborole in pediatric patients 12 years to less than 17 years old. *Information on PK parameters. *Postmarketing study.
|
|
|
|
B,P
|
|
Anacor Pharmaceuticals, Inc.
|
07/18/2018
|
FALSE
|
Antifungal, topical
|
07/31/2018
|
Granix injection
|
tbo-filgrastim
|
Reduce the duration of severe neutropenia in pediatric patients 1 month and older with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia
|
*Safety and effectiveness have been established for pediatric patients 1 month to < 17 years old (no data for the age group < 1 month old). * Use in these age groups is supported by evidence from adequate and well-controlled studies in adults with additional safety and pharmacokinetics data from a single-arm trial of 50 pediatric patients with solid tumors treated with Granix for chemotherapy-induced neutropenia. *The safety profile in the pediatric population is similar to those observed in adults. *Information on adverse reactions, PK parameters, and clinical trial. *Postmarketing study.
|
Labeling
|
|
|
B,P
|
|
Sicor Biotech UAB
|
07/18/2018
|
FALSE
|
Leukocyte growth factor
|
08/02/2018
|
PANZYGA
|
Immune Globulin Intravenous, human-ifas*
|
Indicated for 1) Primary humoral immunodeficiency (PI) in patients 2 years of age and older 2) Chronic immune thrombocytopenic purpura (ITP) in adults
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Octapharma Pharmazeutika Produktionsges.m.b.H.
|
|
FALSE
|
Immunologic agent
|
08/03/2018
|
Nuvessa
|
metronidazole
|
Bacterial vaginosis
|
*Safety and effectiveness have been established in pediatric patients 12 years and older. *Use in this age group of patients 12 to less than 18 years is supported by evidence from a multicenter, open-label safety and tolerability study in 60 pediatric patients with bacterial vaginosis and, evidence from adequate and well-controlled studies in adult women. *Safety and effectiveness in pediatric patients below the age of 12 years have not been established. *Safety was similar to that observed in adults. *Information on adverse reactions and clinical trial. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
Chemo Research SL
|
|
FALSE
|
Antibiotic, topical
|
08/08/2018
|
Jornay PM
|
methylphenidate
|
Attention Deficit Hyperactivity Disorder
|
*Safety and effectiveness have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled clinical studies in pediatric patients 6 to 12 years, pharmacokinetic data in adults, and safety information from other methylphenidate-containing products. *Safety and effectiveness in pediatric patients less than 6 years have not been established. *The long-term efficacy of methylphenidate in pediatric patients has not been established. *Growth should be monitored during treatment with stimulants, including JORNAY PM. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted. *Information on dosing, adverse reactions, clinical trials. *New dosage form.
|
Labeling
|
|
P
|
|
|
Ironshore Pharmaceuticals & Development, Inc.
|
|
FALSE
|
CNS Stimulant
|
08/10/2018
|
Annovera
|
segesterone acetate and ethinyl estradiol vaginal system
|
Prevention of pregnancy
|
*Safety and efficacy of have been established in women of reproductive age. *Efficacy is expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. *Use before menarche is not indicated. *New drug.
|
Labeling
|
|
|
|
|
The Population Council, Inc.
|
|
FALSE
|
Contraceptive
|
08/15/2018
|
Prepopik for oral solution
|
sodium picosulfate, magnesium oxide, and anhydrous citric acid
|
Cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years and older
|
*Safety and effectiveness have been established in pediatric patients 9 years and older. *Use in this age group is supported by evidence from adequate and well-controlled trials of Prepopik in adults and a single, dose-ranging, controlled trial in 78 pediatric patients 9 to 16 years of age. *Safety and effectiveness of Prepopik in pediatric patients less than 9 years of age have not been established. *The safety profile in this pediatric population was similar to that seen in adults. *Monitor for possible hypoglycemia in pediatric patients, as Prepopik has no caloric substrate. *Information on adverse reactions, and clinical trial. *Postmarketing study.
|
|
|
P
|
|
|
Ferring Pharmaceuticals Inc.
|
|
FALSE
|
Osmotic laxative
|
08/22/2018
|
Altreno lotion
|
tretinoin
|
Topical treatment of acne vulgaris
|
*Safety and effectiveness have been established in pediatric patients age 9 years to less than 17 years based on evidence from two multicenter, randomized, double-blind, 12-week trials and an open-label pharmacokinetic study. A total of 318 pediatric subjects aged 9 to less than 17 years received Altreno in the clinical studies. *Safety and effectiveness in pediatric patients below the age of 9 years have not been established. *Information clinical trials, PK parameters, and adverse reactions. *New dosage form.
|
Labeling
|
|
P
|
|
|
Dow Pharmaceutical Sciences, Inc.
|
|
FALSE
|
Antiacne, topical
|
08/29/2018
|
JIVI
|
Antihemophilic Factor (Recombinant), PEGylated-aucl*
|
Use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for: on demand treatment and control of bleeding episodes; perioperative management of bleeding; and routine prophylaxis to reduce the frequency of bleeding episodes
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Bayer HealthCare, Inc.
|
|
FALSE
|
Antihemophilic Factor
|
09/12/2018
|
Actemra
|
tocilizumab
|
Systemic juvenile idiopathic arthritis in pediatric patients 2 through 17 years – Subcutaneous
|
*Approved new subcutaneous dosing and administration for the active systemic juvenile idiopathic arthritis in patients 2 years of age and older. *Information on dosing, clinical trials. *Postmarketing study.
|
Labeling
|
|
|
B, P
|
|
Genentech/Hoffmann-La Roche
|
07/18/2018
|
FALSE
|
Anti-inflammatory
|
09/12/2018
|
Botox
|
onabotulinumtoxinA
|
Prevention of headaches in adolescents with chronic migraine
|
*Safety and effectiveness in patients below the age of 18 years have not been established. *In a 12-week, multicenter, double-blind, placebo-controlled clinical trial, 123 adolescent patients (ages 12 to below 18 years) with chronic migraine were randomized to receive Botox 74 Units, Botox 155 Units, or placebo, for one injection cycle. This trial did not establish the efficacy of Botox, compared with placebo, for the prophylaxis of headaches in adolescents with chronic migraine. *Postmarketing study.
|
|
|
P
|
|
|
Allergan, Inc.
|
|
FALSE
|
Antimigraine
|
09/27/2018
|
Fycompa
|
perampanel
|
Treatment of partial onset seizures (POS), with or without secondarily generalized seizures in patients 4 years and older
|
*Expanded the POS indication to include pediatric patients 4 to less than 12 years; previously approved for use in pediatric patients 12 years and older. *Safety and effectiveness for the POS indication have been not been established in pediatric patients less than 4 years. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
Eisai, Inc.
|
|
FALSE
|
anticonvulsant
|
09/27/2018
|
Promacta for oral suspension
|
eltrombopag
|
Postmarketing study
|
*A new 12.5 mg Powder for Oral Suspension was approved. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
Novartis
|
|
FALSE
|
|
09/28/2018
|
Xolair
|
omalizumab
|
Postmarketing study
|
*New 75 mg and 150 mg liquid prefilled syringes were approved to treat patients 6 years and older with moderate to severe asthma and to treat patients 12 years and older with chronic idiopathic urticaria. *New dosage form.
|
Labeling
|
|
P
|
|
|
Genentech
|
|
FALSE
|
Antiasthmatic; antiallergy
|
10/01/2018
|
Seysara
|
sarecycline
|
Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older
|
*Safety and effectiveness have been established in adult and pediatric patients 9 years and older in two 12-week multicenter, randomized, double-blind, placebo-controlled studies in a total of 2002 patients. *Safety and effectiveness in pediatric patients below the age of 9 years has not been established. *Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration. *Information on Pk parameters, and clinical trials in adults and pediatric patients 9 and older. *New drug.
|
Labeling
|
|
P
|
|
|
Allergan
|
|
FALSE
|
Antiacne, topical
|
10/04/2018
|
AFLURIA; AFLURIA QUADRIVALENT
|
Influenza Vaccine
|
Active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine
|
See Package Insert for new information on biologics
|
https://www.fda.gov/media/81559/download; https://www.fda.gov/media/117022/download
|
|
P
|
|
|
Seqirus, Inc.
|
|
FALSE
|
Preventive Vaccine
|
10/04/2018
|
Lithium
|
lithium
|
Monotherapy treatment of acute manic or mixed episodes of bipolar I disorder and maintenance monotherapy of bipolar I disorder in pediatric patients ages 7 to 17 years
|
*Safety and effectiveness for monotherapy treatment of acute manic or mixed episodes of bipolar I disorder and maintenance monotherapy of bipolar I disorder in pediatric patients ages 7 to 17 years have been established in a clinical trial of 8 weeks in duration followed by a 28-week randomized withdrawal phase. *Safety and effectiveness of lithium has not been established in pediatric patients less than 7 years of age with bipolar I disorder. *Common adverse reactions in pediatric patients 7 to 17 years included nausea/vomiting, polyuria, thyroid abnormalities, tremor, thirst/polydipsia, dizziness, rash/dermatitis, ataxia/gait disturbance, decreased appetite, and blurry vision. *Information on dosing, PK parameters and clinical trials. *Off-patent Written Request.
|
[INVALID]
|
B
|
|
|
|
West-Ward Pharmaceuticals
|
|
FALSE
|
Mood-stabilizing agent
|
10/19/2018
|
Dupixent
|
dupilumab
|
Add-on maintenance treatment in patients with moderate to severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma
|
*Approved for use in adults and pediatric patients 12 years and older. *A total of 107 adolescents aged 12 to 17 years with moderate to severe asthma were enrolled in the clinical trial. *Not indicated for relief of acute bronchospasm or status asthmaticus. *Safety and efficacy in pediatric patients less than 12 years with asthma have not been established. *Safety and efficacy in pediatric patients (<18 years of age) with atopic dermatitis have not been established. *Dupilumab exposure was higher in adolescent patients than that in adults at the respective dose level which was mainly accounted for by difference in body weight. *The adverse event profile in adolescents was generally similar to the adults. *Information on dosage and administration, PK parameters, clinical trial. *New indication, new dupilumab strength.
|
Labeling
|
|
P
|
|
|
Regeneron Pharmaceuticals
|
|
FALSE
|
Antiasthmatic
|
10/24/2018
|
Xofluza
|
baloxavir marboxil
|
Treatment of acute uncomplicated influenza in patients 12 years and older who have been symptomatic for no more than 48 hours
|
*Safety and effectiveness for the treatment of influenza have been established in adults and pediatric patients 12 years and older weighing at least 40 kg. *Safety and effectiveness have not been established in pediatric patients less than 12 years. *Use in pediatric patients 12 years and older weighing at least 40 kg is supported by one randomized, double-blind, controlled trial in which 118 adolescents were randomized to receive either Xofluza (N=80) or placebo (N=38). The median time to alleviation of symptoms in adolescent subjects was 54 hours compared to 93 hours for subjects who received placebo. *Adverse reactions reported in adolescents were similar to those reported in adults. *Information on dosing, adverse reactions, clinical trial and PK parameters in adults and pediatric patients 12 years and older. *New drug.
|
Labeling
|
|
P
|
|
|
Shionogi
|
|
FALSE
|
Antiviral
|
10/26/2018
|
Xyrem
|
sodium oxybate
|
Treatment of cataplexy or excessive daytime sleepiness to pediatric patients 7 years of age and older with narcolepsy
|
*Safety and effectiveness in the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years and older with narcolepsy have been established in a double-blind, placebo-controlled, randomized-withdrawal study. *Safety and effectiveness in pediatric patients below the age of 7 years have not been established. *The adverse reaction profile in the pediatric clinical trial was similar to that seen in the adult clinical trial program. *In the pediatric clinical trial with Xyrem administration in patients with narcolepsy, serious adverse reactions of central sleep apnea and oxygen desaturation; suicidal ideation in one patient; neuropsychiatric reactions including acute psychosis, confusion, and anxiety; and parasomnias, including sleepwalking, have been reported. *Information on dosing, adverse reactions, clinical trial and PK parameters. *Postmarketing study.
|
Labeling
|
B
|
|
|
|
Jazz Pharmaceuticals
|
10/24/2018
|
FALSE
|
CNS Depressant
|
11/07/2018
|
Primatene Mist
|
epinephrine
|
Temporary relief of mild symptoms of intermittent asthma in adults and children 12 years and older
|
*Approved for use in adults and pediatric patients 12 years and older. *Not approved in pediatric patients less than 12 years.
|
|
|
P
|
|
|
Armstrong Pharmaceuticals
|
|
FALSE
|
Antiasthmatic
|
11/09/2018
|
ORALAIR
|
Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract*
|
ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age.
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
Stallergenes
|
|
FALSE
|
Antiallergy
|
11/21/2018
|
Spy Agent Green
|
Indocyanine green
|
Visualization of vessels, blood flow and tissue perfusion before, during, and after various surgical procedures, including minimally invasive surgeries and visualization of extrahepatic biliary ducts
|
*Use for visualization of vessels, blood flow and tissue perfusion has been established in pediatric patients one month and older. *Pediatric use for visualization of vessels, blood flow and tissue perfusion is supported by published data in 49 pediatric patients who received indocyanine green for assessment of blood flow and tissue perfusion in cardiovascular, vascular and plastic, micro and reconstructive procedures, and by clinical trials in adults. *Use for visualization of extrahepatic biliary ducts has been established in pediatric patients aged 12 to 17 years. *Pediatric use for visualization of extrahepatic biliary ducts is supported by clinical trials in adults in addition to clinical use in pediatric patients. *Use of indocyanine green for visualization of extrahepatic biliary ducts has not been established in pediatric patients less 12 years of age. *Safety and efficacy of indocyanine green for visualization of lymph nodes and lymphatic vessels during lymphatic mapping for cervical and uterine tumors has not been established in pediatric patients. *Information on dosing. *New indication and a new route of administration.
|
Labeling
|
|
P
|
|
|
Novadaq Technologies
|
|
FALSE
|
Medical imaging
|
11/29/2018
|
Astagraf XL
|
tacrolimus
|
Prophylaxis of organ rejection in kidney transplant patients, in combination with other immunosuppressants.
|
*Safety and effectiveness of Astagraf XL in de novo pediatric kidney transplant patients have been established. *Use in pediatric kidney transplant patients is based on adequate and well controlled studies of Astagraf XL in adult kidney transplant patients and supported by pharmacokinetic and safety data in pediatric transplant patients 4 years of age and older who are able to swallow capsules intact and Prograf (tacrolimus) capsules in adult and pediatric transplant patients. *A pharmacokinetic and safety study included 25 de novo pediatric kidney transplant patients, 4 to 15 years of age, randomized and treated with either Prograf (n=12) or Astagraf XL (n=13). *Another pharmacokinetic and safety study included 48 stable pediatric kidney transplant patients, 5 to 16 years of age, who were converted from a Prograf-based regimen to Astagraf XL. *Information on dosing, clinical trials, adverse reactions and PK parameters. *Postmarketing study.
|
Labeling
|
|
P
|
|
|
Astellas
|
|
FALSE
|
Immunologic agent
|
12/11/2018
|
Viread
|
tenofovir disoproxil fumarate
|
Chronic hepatitis B (CHB) in pediatric patients 2 years and older weighing at least 10 kg
|
*Safety and effectiveness in pediatric patients 2 years to less than 18 years of age is supported by data from two randomized trials in which Viread was administered to HBV-infected treatment-experienced patients. *Safety and effectiveness in chronic HBV-infected pediatric patients younger than 2 years and weighing less than 10 kg have not been established. *The effects of Viread-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk in chronic HBV-infected pediatric patients 2 years and older are unknown. The long-term effect of lower spine and total body BMD on skeletal growth in pediatric patients 2 years and older, and in particular, the effects of long-duration exposure in younger children is unknown. *Information on dosing, adverse reactions, and clinical trials. *New indication.
|
Labeling
|
|
|
B,P
|
|
Gilead
|
11/15/2018
|
FALSE
|
Antiviral
|
12/12/2018
|
Exjade; Jadenu
|
deferasirox
|
Transfusion-dependent anemia requiring chelation therapy due to iron overload
|
*A trial conducted in treatment naïve pediatric patients, ages 2 years to less than 18 years with transfusional iron overload did not include a sufficient number of patients to provide additional meaningful information about the safety or compliance of the deferasirox oral tablet for suspension dosage form (Exjade) compared to the deferasirox granules dosage form (Jadenu Sprinkle).
|
Labeling
|
B
|
|
|
|
Novartis
|
|
FALSE
|
Iron chelator
|
12/21/2018
|
Sprycel
|
dasatinib
|
Pediatric patients one year and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy
|
*Safety and effectiveness of Sprycel in combination with chemotherapy have been demonstrated in pediatric patients one year and over with newly diagnosed Ph+ ALL. *Use in pediatric patients is supported by evidence from one pediatric study. There are no data in children under 1 year. *The safety profile in pediatric patients was comparable to that reported in studies in adults. *Monitor bone growth and development in pediatric patients. *Five patients with Ph+ ALL 2 to 10 years of age received at least one dose of SPRYCEL tablet dispersed in juice. The exposure for dispersed tablets was 36% lower as compared to intact tablets in pediatric patients. Due to the limited available clinical data, it is unclear whether dispersing Sprycel tablets significantly alters the safety and/or efficacy of Sprycel. *New indication.
|
Labeling
|
|
|
B,P
|
|
Bristol-Myers Squibb Company
|
09/27/2018
|
FALSE
|
Antineoplastic
|
12/21/2018
|
VAXELIS
|
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine*
|
Active immunization against diphtheria, tetanus, pertussis, poliomyelitis (caused by poliovirus Types 1, 2, and 3), against invasive disease caused by Haemophilus influenzae type b and infection caused by all known subtypes of hepatitis B virus in children 6 weeks through 4 years of age
|
See Package Insert for new information on biologics
|
Labeling
|
|
P
|
|
|
MCM Vaccine Company
|
|
FALSE
|
Preventive Vaccine
|
01/25/2019
|
Zovirax
|
acyclovir sodium
|
Neonatal herpes virus infection (HSV)
|
*New dose: Post Menstrual Age (PMA) of at least 34 Weeks: 20 mg/kg every 8 hours for 21 days. PMA of less than 34 Weeks: 20 mg/kg every 12 hours for 21 days. Previously approved dose: Birth to 3 months: 10 mg/kg every 8 hours for 10 days. *In an open-label clinical trial, Zovirax 20 mg/kg every 8 hours (60 mg/kg/day) was compared with 15 mg/kg every 8 hours (45 mg/kg/day) to neonates =28 days old with suspected HSV infection. In total, 88 neonates were enrolled in the trial and received IV acyclovir for 21 days. The mean gestational ages (GA) were 37.5 and 37.9 weeks for the 45-mg/kg/day and 60-mg/kg/day doses, respectively. The number of premature infants (=37 weeks GA) receiving 45 mg/kg/day and 60 mg/kg/day were 7 (54%) and 22 (33%), respectively. *Among 69 patients with proven systemic (disseminated or CNS) herpes infection, 57 were randomized to receive Zovirax (20 mg/kg every 8 hours) while the remaining 12 patients received a lower dose of Zovirax every 8 hours. *Overall, the mortality among patients treated with Zovirax 20 mg/kg every 8 hours was lower compared with patients who received a lower dose of Zovirax. *Information on dosing and clinical trial. *Off-patent written request.
|
Labeling
|
B
|
|
|
|
GlaxoSmithKline
|
|
FALSE
|
Antiviral
|
01/29/2019
|
Vfend
|
voriconazole
|
(1) Invasive aspergillosis (2) Candidemia and disseminated candidiasis in skin, abdomen, kidney, bladder wall, and wounds (3) Esophageal candidiasis (4) Serious infections caused by Scedosporium apiospermum and Fusarium species in patients intolerant of, or refractory to, other therapy.
|
• Expanded indications down to 2 years; previously approved in 12 years and older. • Safety and effectiveness have been established in pediatric patients 2 years of age and older based on evidence from adequate and well-controlled studies in adult and pediatric patients and additional pediatric pharmacokinetic and safety data. A total of 105 pediatric patients aged 2 to less than 12 [N=26] and aged 12 to less than 18 [N=79] from two, non-comparative Phase 3 pediatric studies and eight adult therapeutic trials provided safety information for Vfend use in the pediatric population. • Safety and effectiveness in pediatric patients below the age of 2 years has not been established. Therefore, Vfend is not recommended for pediatric patients less than 2 years of age. • The frequency of phototoxicity reactions is higher in the pediatric population. Squamous cell carcinoma has been reported in patients who experience photosensitivity reactions. [INVALID]nt measures for photoprotection are warranted. Sun avoidance and dermatologic follow-up are recommended in pediatric patients experiencing photoaging injuries, such as lentigines or ephelides, even after treatment discontinuation. • A higher frequency of liver enzyme elevations was observed in the pediatric patients. Hepatic function and serum creatinine levels should be closely monitored in pediatric patients. • There have been postmarketing reports of pancreatitis in pediatric patients. • Information on dosing, adverse reactions, PK parameters, and clinical studies. • Postmarketing study
|
Labeling
|
|
|
B,P
|
|
C.V. PF PRISM
|
|
FALSE
|
Antifungal
|
02/19/2019
|
ESPEROCT
|
Antihemophilic Factor (Recombinant), GlycoPEGylated-exei*
|
For use in adults and children with hemophilia A for: • On-demand treatment and control of bleeding episodes • Perioperative management of bleeding • Routine prophylaxis to reduce the frequency of bleeding episodes
|
See Package Insert for new information on biologics
|
https://www.fda.gov/media/120351/download
|
|
P
|
|
|
Novo Nordisk, Inc.
|
|
FALSE
|
Antihemophilic Factor
|
02/22/2019
|
Chantix
|
varenicline
|
Aid to smoking cessation treatment
|
*Chantix is not recommended for use in pediatric patients 16 years or younger because its efficacy in this population was not demonstrated. *Efficacy and safety of varenicline were evaluated in a randomized, double-blind, placebo-controlled study of 312 patients aged 12 to 19 years. Results from this study showed that varenicline, at either dose studied, did not improve continuous abstinence rates at weeks 9 through 12 of treatment compared with placebo in patients 12 to 19 years. *Varenicline safety profile in this study was consistent with that observed in adult studies. *Information on pharmacokinetics.
|
|
|
|
B,P
|
|
PF Prism CV
|
11/15/2018
|
FALSE
|
Smoking cessation
|
02/27/2019
|
Adhansia XR
|
methylphenidate hydrochloride
|
Attention Deficit Hyperactivity Disorder
|
*Safety and effectiveness have been established in one adequate and well-controlled 6-week study in pediatric patients ages 6 to 12 years, and in one adequate and well-controlled 4-week study in pediatric patients ages 12 to 17 years. *Safety and effectiveness in pediatric patients under the age of 6 years have not been established. *The long-term efficacy of methylphenidate in pediatric patients has not been established. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *New dosage form.
|
|
|
P
|
|
|
Purdue Pharma L.P.
|
|
FALSE
|
CNS Stimulant
|
03/01/2019
|
Flector Topical System
|
diclofenac epolamine
|
Topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older
|
*Safety and effectiveness have been established in pediatric patients 6 years and older based on evidence from adequate and well-controlled studies in adults, as well as an open-label study in 104 pediatric patients 6 years and older. *The safety profile of Flector topical system in pediatric patients is similar to that in adults. *Safety and effectiveness have not been investigated in pediatric patients less than 6 years old. *Information on adverse reactions, PK parameters and clinical trial. *Postmarketing study.
|
[INVALID]
|
|
P
|
|
|
Institut Biochimique SA
|
|
FALSE
|
Anti-inflammatory, topical
|
03/11/2019
|
Dupixent
|
dupilumab
|
Moderate-to-severe atopic dermatitis
|
*Safety and efficacy have been established in pediatric patients 12 years and older. *A total of 251 adolescents ages 12 to 17 years old with moderate-to-severe atopic dermatitis were enrolled in the clinical trial. *Safety and efficacy in pediatric patients less than12 years with atopic dermatitis have not been established. *The safety profile in pediatric patients is similar to that in adults. *Information on adverse reactions, PK parameters and clinical trial. *Postmarketing study.
|
[INVALID]
|
|
P
|
|
|
Regeneron Pharmaceuticals
|
|
FALSE
|
Monoclonal antibody
|
03/14/2019
|
Avycaz
|
ceftazidime/ avibactam
|
Treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) to include patients 3 months to less than 18 years
|
*Safety and effectiveness in the treatment of cUTI and cIAI have been established in pediatric patients 3 months to less than 18 years. Use in these age groups is supported by evidence from adequate and well-controlled studies of Avycaz in adults with cUTI and cIAI and additional pharmacokinetic and safety data from pediatric trials. *Safety and effectiveness in pediatric patients below the age of 3 months with cUTI or cIAI have not been established. *Safety and effectiveness in pediatric patients less than 18 years of age with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia have not been established. *Dosage adjustment is required in pediatric patients with cIAI or cUTI and renal impairment from 2 years to < 18 years with eGFR 50 mL/min/1.73 m2 or less. There is insufficient information to recommend a dosing regimen for pediatric patients younger than 2 years of age with cIAI or cUTI and renal impairment. * Safety in patients ages 3 months to less than 18 years was similar to that observed in adults. *Information on recommended dosing, dosing in renal impairment patients, PK parameters and clinical trials in patients ages 3 months to less than 18 years. *Postmarketing study.
|
[INVALID]
|
|
P
|
|
|
Allergan
|
|
FALSE
|
Antibiotic
|
03/21/2019
|
Doptelet
|
avatrombopag
|
Juvenile animal toxicity study
|
•Safety and effectiveness in pediatric patients have not been established. • In a 10-week juvenile toxicology study in rats, avatrombopag was administered at doses ranging from 20 to 300 mg/kg/day. There were no test article-related mortality or clinical signs at doses up to 300 mg/kg/day. In the stomach, dose-dependent degeneration, regenerative hyperplasia, and atrophy of the glandular epithelium occurred at 100 and 300 mg/kg/day; exposures at 100 mg/kg/day in male rats were 14-times the AUC in patients at the recommended dose of 60 mg once daily. An increased incidence of background focal mineralization was also observed in the kidneys of females at 300 mg/kg/day (female rat exposure was 50-times the human exposure based on AUC at the 60 mg daily dose). •Postmarketing study
|
[INVALID]
|
|
P
|
|
|
AkaRx, Inc.
|
|
FALSE
|
|
03/29/2019
|
Octaplas
|
Pooled Plasma (Human), Solvent/Detergent Treated*
|
Indicated (1) as replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or undergoing cardiac surgery and liver transplantation and (2) plasma exchange in patients with thrombotic thrombocytopenic purpura
|
See Package Insert for new information on biologics
|
|
|
P
|
|
|
Octapharma USA, Inc.
|
|
FALSE
|
Pooled human plasma
|
04/03/2019
|
Welchol Chewable Bar
|
colesevelam HCl
|
Reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia as monotherapy or in combination with a statin after failing an adequate trial of diet therapy
|
*New Chewable Bars: 3.75 gram per bar. *Information on dosing and administration. *New dosage form.
|
[INVALID]
|
|
P
|
|
|
Daiichi Sankyo
|
|
FALSE
|
Antilipemic
|
04/18/2019
|
Opdivo
|
nivolumab
|
Treatment of patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC)
|
*New recommended dosage regimens for nivolumab for the treatment of patients with MSI-H or dMMR mCRC in adults and pediatric patients. *Additionally, a modification of the recommended dosage regimen for nivolumab in adult and pediatric patients 12 years and older with MSI-H or dMMR mCRC for OPDIVO 240 mg intravenously over 30 minutes every 2 weeks until disease progression or unacceptable toxicity, to limit this dosage regimen to adult and pediatric patients weighing 40 kg or more. *Postmarketing study.
|
[INVALID]
|
|
P
|
|
|
Bristol-Myers Squibb
|
|
FALSE
|
Antineoplastic
|
04/22/2019
|
Corlanor Oral Solution
|
ivabradine
|
Treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate
|
*Safety and effectiveness have been established in pediatric patients age 6 months to less than 18 years old and are supported by pharmacokinetic and pharmacodynamic trials and evidence from adequate and well-controlled trials of Corlanor in adult patients. *The pediatric study included 116 patients in the following age groups: 17 patients in the 6 months to less than 12 months age group, 36 patients in the 1 year to less than 3 years age group, and 63 patients in the 3 years to less than 18 years age group. *Safety and efficacy have not been established in patients less than 6 months of age. *Bradycardia and first-degree heart block were observed in pediatric patients treated with Corlanor. *Asymptomatic and symptomatic bradycardia were observed in 6.8% and 4.1% of pediatric patients treated with Corlanor, respectively. *Phosphenes were observed in pediatric patients treated with Corlanor. *Information on dosing, adverse reactions, PK parameters and clinical trial. *New dosage form.
|
[INVALID]
|
B
|
|
|
|
Amgen
|
03/30/2019
|
FALSE
|
Heart failure
|
04/26/2019
|
Benlysta
|
belimumab
|
Treatment of patients with active, antibody systemic lupus erythematosus (SLE) to include children aged 5 to 17 years
|
*Expanded indication to pediatric patients 5 to 17 years. *Determination of efficacy in pediatric patients was based on pharmacokinetic (PK) and efficacy results from a pediatric SLE study, as well as PK exposure and extrapolation of the established efficacy of Benylsta plus standard therapy from the Phase 3 intravenous studies in adults. A randomized, double-blind, placebo-controlled, PK, efficacy, and safety study to evaluate intravenously administered Benlysta 10 mg/kg plus standard therapy compared with placebo plus standard therapy over 52 weeks was conducted in 93 pediatric patients with SLE. The proportion of pediatric patients achieving an SRI-4 response was higher in patients receiving Benlysta plus standard therapy compared with placebo plus standard therapy. *Pediatric patients receiving Benlysta plus standard therapy also had a lower risk of experiencing a severe flare compared with the placebo group. *The adverse event profile in pediatric patients was consistent with the overall population in the Phase 3 studies in adults. *Safety and effectiveness of have not been established in pediatric patients younger than 5 years of age. *Safety and effectiveness of subcutaneous administration of Benlysta have not been established in pediatric patients younger than 18 years of age. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *Postmarketing study.
|
[INVALID]
|
|
P
|
|
|
Human Genome Sciences, Inc.
|
|
FALSE
|
Immunosuppressant
|
04/30/2019
|
Mavyret
|
glecaprevir and pibrentasvir
|
Chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)
|
*Expanded the indication to adolescents 12 years and older or weighing at least 45 kilograms (kg); previously approved in adults. *Safety, efficacy, and pharmacokinetics in HCV GT1, 2, 3, or 4 infected pediatric patients 12 years and older or weighing at least 45 kg is based on data from an open-label trial in 47 subjects without cirrhosis aged 12-18 years who were either treatment naïve (n=36) or treatment experienced (n=11) and received Mavyret for 8 or 16 weeks. *The safety and efficacy results observed in this trial were consistent with those observed in clinical studies of Mavyret in adults. *In pediatric patients with cirrhosis, history of a kidney and/or liver transplant, or HCV GT5 or 6 infection, the safety and efficacy of Mavyret are supported by the comparable glecaprevir and pibrentasvir exposures observed between adolescents and adults. *Safety and effectiveness in children less than 12 years of age have not been studied. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *Postmarketing study.
|
[INVALID]
|
|
|
B, P
|
|
AbbVie
|
|
FALSE
|
Antiviral
|
05/01/2019
|
DENGVAXIA
|
DENGUE Tetravalent Vaccine, Live*
|
Indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. DENGVAXIA is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.
|
See Package Insert for new information on biologics
|
|
|
P
|
|
|
Sanofi Pasteur
|
|
FALSE
|
Preventive Vaccine
|
05/06/2019
|
Sorilux
|
calcipotriene
|
Topical treatment of plaque psoriasis of the scalp and body in patients 12 years and older
|
*Safety and effectiveness have been established in pediatric patients age 12 years and older for topical treatment of plaque psoriasis of the scalp and body. *Use of in this age group is supported by two adequate and well controlled 8-week trials in adults and adolescents 12 years and older, with additional data from an open-label safety and pharmacokinetics study. *The safety and effectiveness of in pediatric patients less than 12 years of age have not been established. *Information on adverse reactions, PK parameters, and clinical trials.
|
|
|
P
|
|
|
Mayne Pharma International
|
|
FALSE
|
Antipsoriatic, topical
|
05/07/2019
|
Sutent
|
sunitinib malate
|
Refractory solid tumors
|
*Safety and effectiveness in pediatric patients have not been established. *Safety and pharmacokinetics were assessed in an open-label study in pediatric patients 2 years to <17 years of age (n=29) with refractory solid tumors. In addition, efficacy, safety and pharmacokinetics was assessed in another open-label study in pediatric patients 2 years to <17 years (n=27) with high-grade glioma or ependymoma. *The maximum tolerated dose normalized for body surface area was lower in pediatric patients compared to adults. *Sunitinib was poorly tolerated in pediatric patients. *The effect on open tibial growth plates in pediatric patients who received Sutent has not been adequately studied. *Information on adverse reactions and clinical trials.
|
|
B
|
|
|
|
C.P. Pharmaceuticals International C.V.
|
02/07/2019
|
FALSE
|
Antineoplastic
|
05/15/2019
|
Gattex
|
teduglutide
|
Short Bowel Syndrome (SBS) in pediatric patients 1 year of age and older
|
*Safety and effectiveness of Gattex have been established in pediatric patients 1 year to less than 17 years of age who are dependent on parenteral support for the treatment of SBS. *Use of Gattex in this population is supported by evidence from adequate and well-controlled studies in adults, with additional efficacy, safety, pharmacokinetic and pharmacodynamic data in pediatric patients 1 year to less than 17 years of age. There were 41 pediatric patients treated with Gattex: 1 infant (1 year to less than 2 years), 37 children (2 years to less than 12 years) and 3 adolescents (12 years to less than 17 years). *Safety and effectiveness in pediatric patients less than 1 year of age have not been established. *Adverse reactions in pediatric patients were similar to those seen in adults. *Information on dosing, adverse reactions, PK parameters and clinical trials.
|
|
|
P
|
|
|
Shire-NPS Pharmaceuticals, Inc.
|
|
FALSE
|
Glucagon-like peptide-2 (GLP-2) analog
|
05/16/2019
|
Fragmin
|
dalteparin sodium
|
Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients 1 month and older
|
*Safety and effectiveness for the treatment of symptomatic VTE have been established in pediatric patients aged 1 month and older. *Use is supported by evidence from well-controlled studies in adults with additional pharmacokinetic, pharmacodynamic, efficacy, and safety data from two separate studies in pediatric patients aged 1 month and older with symptomatic VTE. *The frequency, type and severity of adverse reactions observed were generally consistent with those observed in adults. *Use preservative-free FRAGMIN in neonates and infants. *Serious adverse reactions including fatal reactions and the "gasping syndrome' occurred in premature neonates and low-birth weight infants in the neonatal intensive care unit who received benzyl alcohol preserved medications. *Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. *When prescribing Fragmin multiple-dose vials in infants consider the combined daily metabolic load of benzyl alcohol from all sources including FRAGMIN multiple-dose vials and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. *Information on dosing, adverse reaction, PK parameters, and clinical trials.
|
|
|
P
|
|
|
Pharmacia & Upjohn
|
|
FALSE
|
Anticoagulant
|
05/16/2019
|
Livalo
|
pitavastatin
|
Heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and Apo B in pediatric patients 8 years and older
|
*Safety and effectiveness of LIVALO as an adjunctive therapy to diet to reduce elevated TC, LDL-C, and Apo B in pediatric patients aged 8 years and older with HeFH have been established. *Use of LIVALO for this indication is supported by a 12-week, double-blind, placebo-controlled trial in 82 pediatric patients 8 to 16 years of age with HeFH and a 52-week open-label trial in 85 pediatric patients with HeFH. *Safety and effectiveness have not been established in pediatric patients younger than 8 years with HeFH or in pediatric patients with other types of hyperlipidemia (other than HeFH). *Adverse reactions in pediatric patients were similar to those observed in adults. *Information on dosing, adverse reactions, clinical trial
|
|
|
P
|
|
|
Kowa Pharmaceuticals America, Inc.
|
|
FALSE
|
Antilipemic
|
05/23/2019
|
Lyrica
|
pregabalin
|
Treatment of partial-onset seizures (POS), to include pediatric patients 1 month to less than 4 years
|
*Safety and effectiveness as adjunctive treatment for POS in pediatric patients 1 month to less than 4 years have been established in a 14-day double-blind, placebo-controlled study (N=175). Previously approved in 4 years and older. *The youngest subject evaluated was 3 months of age; use in patients 1 month to less than 3 months of age is supported by additional pharmacokinetic analyses. *Safety and effectiveness in pediatric patients below the age of 1 month have not been established. *The most common dose-related adverse reactions (>5%) with Lyrica in this study were somnolence, pneumonia, and viral infection. *Information on dosing, adverse reactions, PK parameters, and clinical trial. *Postmarketing study.
|
|
|
|
B,P
|
|
PF Prism CV
|
11/21/2018
|
FALSE
|
Anticonvulsant
|
05/23/2019
|
Slynd
|
drospirenone
|
Prevention of pregnancy
|
*Safety and efficacy have been established in females of reproductive age. Safety and efficacy are expected to be the same for post-pubertal adolescents under the age of 16 and users 16 years and older. *Study CF111/304 evaluated the bleeding associated with Slynd in females =12 years of age. Bleeding data were generally consistent with those from Study CF111/303 in adult females. *Use of this product before menarche is not indicated. *New dosage form.
|
|
|
P
|
|
|
Exeltis USA, Inc.
|
|
FALSE
|
Contraceptive
|
06/06/2019
|
Nucala
|
mepolizumab
|
Add-on maintenance treatment of patients with severe asthma aged 12 years and older
|
*New liquid formulation approved for subcutaneous injection via Autoinjector (AI) or Safety Syringe Device (SSD). *This formulation is approved for the same dosages, route of administration (SC), and indications for the new SSD and AI presentations as the approved lyophilized drug product. *New dosage form.
|
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE
|
Antiasthmatic
|
06/14/2019
|
Aptensio XR
|
methylphenidate hydrochloride
|
Attention Deficit Hyperactivity Disorder (ADHD)
|
*Safety and effectiveness in pediatric patients under 6 years have not been established. *Safety and efficacy were evaluated in a multicenter, placebo-controlled, double-blind, parallel group study in 119 children 4 to <6 years with ADHD followed by a 12-month open-label extension in 44 of these children. *In these studies, patients experienced high rates of adverse reactions, most notably weight loss. Comparing weights prior to initiation of Aptensio XR (in the safety and efficacy study) to weights after 12 months of treatment (in the open-label extension), 20 of 39 patients with data (50%) had lost enough weight to decrease 10 or more percentiles on a Centers for Disease Control growth chart for weight. In addition, systemic drug exposures in patients 4 to <6 years of age were higher than those observed in older children and adolescents at the same dose (2 to 3 fold higher Cmax and AUC). *Therefore, the benefits do not outweigh the risks in pediatric patients 4 to <6 years. *Postmarketing study.
|
|
|
P
|
|
|
Rhodes Pharmaceuticals L.P.
|
|
FALSE
|
CNS Stimulant
|
06/17/2019
|
Victoza
|
liraglutide
|
Treatment of type 2 diabetes mellitus in pediatric patients ages 10 years and older
|
*Safety and effectiveness as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients 10 years of age and older. *Use for this indication is supported by a 26-week placebo-controlled clinical trial and a 26-week open-label extension in 134 pediatric patients 10 to 17 years with type 2 diabetes, a pediatric pharmacokinetic study, and studies in adults with type 2 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients less than 10 years of age. *The risk of hypoglycemia was higher with Victoza in pediatric patients regardless of concomitant antidiabetic therapies. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *Postmarketing study.
|
|
|
|
B,P
|
|
Novo Nordisk
|
05/01/2019
|
FALSE
|
Antidiabetic
|
06/18/2019
|
Biktarvy
|
bictegravir, emtricitabine, and tenofovir alafenamide
|
HIV-1 infected pediatric patients weighing at least 25 kg
|
*Safety and effectiveness were established in pediatric patients with body weight greater than or equal to 25 kg. *Use in pediatric patients between the ages of 6 to less than 18 years and weighing at least 25 kg is supported by trials in adults and by an open-label trial of 100 pediatric patients. *Safety and effectiveness in pediatric patients weighing less than 25 kg have not been established. *There was no clinically significant change in exposure for the components of Biktarvy. *Adverse reactions in pediatric patients were similar to those observed in adults. *Information on dosing, adverse reactions, clinical trials, and PK parameters. *Postmarketing study.
|
|
|
P
|
|
|
Gilead
|
|
FALSE
|
Antiviral
|
06/20/2019
|
Botox
|
onabotulinumtoxinA
|
Treatment of upper limb spasticity in pediatric patients 2 to 17 years of age
|
*Safety and effectiveness for the treatment of upper limb spasticity have been established in pediatric patients 2 to 17 years of age, in a clinical study of 234 patients. *Safety and effectiveness in pediatric patients below the age of 2 years have not been established. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study.
|
|
|
P
|
|
|
Allergan
|
|
FALSE
|
Antispasmodic
|
07/08/2019
|
Katerzia oral suspension
|
amlodipine benzoate
|
Hypertension in children 6 years and older
|
*New oral suspension 1 mg/mL approved in pediatric patients 6 years and older. *New dosage form.
|
|
|
P
|
|
|
Silvergate Pharmaceuticals, Inc.
|
|
FALSE
|
Antihypertensive
|
07/24/2019
|
Baqsimi nasal powder
|
glucagon
|
Treatment of severe hypoglycemia in patients with diabetes ages 4 years and older
|
*Safety and effectiveness for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients ages 4 years and above. Use for this indication is supported by evidence from a study in 48 pediatric patients from 4 to <17 years of age with type 1 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients younger than 4 years. *Information on dosing and administration, adverse reactions, clinical trials, and pharmacokinetics and pharmacodynamics. *New dosage form.
|
|
|
P
|
|
|
Eli Lilly
|
|
FALSE
|
Antihypoglycemic
|
07/25/2019
|
Taclonex Topical Suspension
|
calcipotriene and betamethasone dipropionate
|
Plaque psoriasis of the scalp and body in patients 12 years and older
|
*Safety and effectiveness for the treatment of plaque psoriasis of the scalp and body have been established in pediatric patients age 12 to 17 years. *Use for this indication is supported by evidence from adequate and well-controlled trials in adults and from three uncontrolled trials in 216 adolescents. *After 4 weeks of once daily treatment, HPA axis suppression was observed in 3% of adolescents with psoriasis of the scalp and 16% of adolescents with psoriasis of the scalp and body. *Safety and effectiveness in pediatric patients less than 12 years have not been established. *Information on safety, adverse reactions, and pharmacodynamics. *Postmarketing study.
|
|
|
P
|
|
|
LEO Pharm A/S
|
|
FALSE
|
Anti-inflammatory, topical
|
07/30/2019
|
Enstilar Foam
|
calcipotriene and betamethasone dipropionate
|
Topical treatment of plaque psoriasis in patients 12 years and older
|
*Safety and effectiveness for the treatment of plaque psoriasis of the scalp and body have been established in pediatric patients age 12 to 17 years. *Use for this indication is supported by evidence from adequate and well-controlled trials in adults and from three uncontrolled trials in 216 adolescents. *After 4 weeks of once daily treatment, HPA axis suppression was observed in 3% of adolescents with psoriasis of the scalp and 16% of adolescents with psoriasis of the scalp and body. *Safety and effectiveness in pediatric patients less than 12 years have not been established. *Information on safety, adverse reactions, and pharmacodynamics. *Postmarketing study.
|
|
|
|
B,P
|
|
LEO Pharm A/S
|
|
FALSE
|
Anti-inflammatory, topical
|
08/08/2019
|
Clenpiq
|
sodium picosulfate, magnesium oxide, and anhydrous citric acid
|
Cleansing of the colon as a preparation for colonoscopy to pediatric patients 9 years and older
|
*Safety and effectiveness have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 9 years and older. *Use in this age group is supported by evidence from adequate and well-controlled trials in adults and a single, dose-ranging, controlled trial in 78 pediatric patients 9 to 16 years of age all of which evaluated another oral product of sodium picosulfate, magnesium oxide, and anhydrous citric acid. *The safety profile in this pediatric population was similar to that seen in adults. *Monitor for possible hypoglycemia in pediatric patients, as Clenpiq has no caloric substrate. *Safety and effectiveness in pediatric patients less than 9 years have not been established. *Information on dosing, adverse reactions, PK parameters, and clinical trial. *Postmarketing study.
|
|
|
P
|
|
|
Ferring International
|
|
FALSE
|
|
08/12/2019
|
Asmanex HFA
|
mometasone furoate
|
Asthma in pediatric patients 5 -11 years
|
*Expanded indication to pediatric patients 5 to 11 years; previously approved in pediatric patients 12 years and older. *Safety and effectiveness have not been established in children younger than 5 years. *Safety profile for pediatric patients is similar to that observed in patients aged 12 years and older. *New Asmanex HFA 50 mcg/5 mcg metered dose inhaler. *Information on dosing, adverse reactions, clinical trial. *Postmarketing study.
|
|
|
P
|
|
|
Merck Sharp & Dohme
|
|
FALSE
|
Antiasthmatic
|
08/12/2019
|
Dulera Inhalation Aerosol
|
formoterol fumarate/mometasone furoate
|
Asthma in pediatric patients 5 -11 years
|
*Expanded indication to pediatric patients 5 to 11 years; previously approved in pediatric patients 12 years and older. *Safety and effectiveness have not been established in children younger than 5 years. *Safety profile for pediatric patients is similar to that observed in patients aged 12 years and older. *New Dulera 50 mcg/5 mcg metered dose inhaler. *Information on dosing, PK parameters, adverse reactions, lab abnormalities, and clinical trial. *Postmarketing study.
|
|
|
|
B,P
|
|
Merck Sharp & Dohme
|
06/24/2019
|
FALSE
|
Antiasthmatic
|
08/15/2019
|
Rozlytrek
|
entrectinib
|
Treatment of adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion with a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity
|
|
*Safety and effectiveness in pediatric patients aged 12 years and older with solid tumors that have an NTRK gene fusion have been established. *The effectiveness in adolescent patients was established based on extrapolation of data from three open-label, single-arm clinical trials in adult patients with solid tumors harboring an NTRK gene fusion (ALKA, STARTRK-1, and STARTRK-2) and pharmacokinetic data in adolescents enrolled in STARTRK-NG. *Safety in pediatric patients 12 years and older was established based on extrapolation of data in adults and data from 30 pediatric patients enrolled in STARTRK-NG. *Due to the small number of pediatric and adult patients, it is not possible to determine whether the observed differences in the incidence of adverse reactions to Rozlytrek are related to patient age or other factors. In an expanded safety database that included 338 adult patients and 30 pediatric patients who received Rozlytrek across clinical trials, the Grade 3 or 4 adverse reactions and laboratory abnormalities that occurred more frequently in pediatric patients (n = 30) compared with adults (n = 338) were neutropenia (27% vs 2%), bone fractures (23% vs 5%), increased weight (20% vs 7%), thrombocytopenia (10% vs 0.3%), lymphopenia (7% vs 1%), increased gamma-glutamyl transferase (7% vs 0%), and device-related infection (7% vs 0.3%). *Safety and effectiveness in pediatric patients less than 12 years with solid tumors who have an NTRK gene fusion have not been established. *Safety and effectiveness in pediatric patients with ROS1-positive NSCLC have not been established. *Information on dosing, PK parameters, adverse reactions including drug-drug interactions, lab abnormalities, and clinical trial. *New drug.
|
B
|
|
|
|
Genentech
|
|
FALSE
|
Antineoplastic
|
08/22/2019
|
Tybost
|
cobicistat
|
HIV-1 infection in pediatric patients weighing = 35 kg
|
*Safety and effectiveness co -administered with atazanavir and two nucleoside reverse transcriptase inhibitors for the treatment of HIV-1 infection have been established in virologically suppressed pediatric patients weighing at least 35 kg. *Use for this indication is supported by evidence from adequate and well-controlled studies in adults, and by pharmacokinetic, safety, and virologic data from an open-label trial in virologically suppressed, HIV-1 infected pediatric patients 12 years and older. *Safety through 48 weeks was similar to that in antiretroviral treatment-naïve adults. *Safety and effectiveness in combination with atazanavir in pediatric patients weighing less than 35 kg have not been established. *Safety and effectiveness in combination with darunavir in pediatric patients have not been established. *Information on dosing, PK parameters, adverse reactions, and clinical trial. *Postmarketing study.
|
|
|
|
B,P
|
|
Gilead Sciences, Inc.
|
|
FALSE
|
Antiviral
|
08/28/2019
|
Harvoni Oral Pellets
|
ledipasvir and sofosbuvir
|
Treatment of chronic hepatitis C virus
|
*Expanded indication to pediatric patients 3 to 11 years; previously approved in pediatric patients 12 years and older. *Safety and efficacy have not been established in pediatric patients less than 3 years of age. *Adverse reactions were similar to those observed in adults. *Information on dosing, preparation and administration of oral pellets, PK parameters, adverse reactions, clinical trial. *New dosage form.
|
|
|
|
B,P
|
|
Gilead Sciences, Inc.
|
07/23/2019
|
FALSE
|
Antiviral
|
08/28/2019
|
Harvoni
|
ledipasvir and sofosbuvir
|
Treatment of pediatric patients 3 to less than 12 years, weighing at least 17 kg, with chronic hepatitis C virus (HCV)
|
*Expanded indication to pediatric patients 3 to 11 years; previously approved in pediatric patients 12 years and older. *Safety and efficacy have not been established in pediatric patients less than 3 years of age. *Adverse reactions were similar to those observed in adults. *Information on dosing, PK parameters, adverse reactions, clinical trial. *New dosage form.
|
|
|
|
B,P
|
|
Gilead Sciences, Inc.
|
07/23/2019
|
FALSE
|
Antiviral
|
08/28/2019
|
Sovaldi
|
sofosbuvir
|
Treatment of chronic hepatitis C virus
|
* Expanded indication to pediatric patients 3 to 11 years ; previously approved in pediatric patients 12 years and older. *Safety and efficacy have not been established in pediatric patients less than 3 years of age. *Adverse reactions were similar to those observed in adults. *Information on dosing, preparation and administration of oral pellets, PK parameters, adverse reactions, clinical trial. *Two new dosage forms: oral pellets and 200 mg tablet
|
|
|
|
B,P
|
|
Gilead Sciences, Inc.
|
|
FALSE
|
Antiviral
|
08/29/2019
|
Riomet ER
|
metformin hydrochloride
|
Type 2 diabetes mellitus in pediatric patients 10 years and older
|
*Safety and effectiveness as an adjunct to diet and exercise to improve glycemic control in pediatric patients 10 years and older with type 2 diabetes mellitus have been established. *Use of for this indication is supported by evidence from adequate and well-controlled studies of metformin HCl immediate-release tablet in adults with additional data from a controlled clinical study using metformin HCl immediate-release tablets in 73 pediatric patients 10 to 16 years old with type 2 diabetes mellitus. *Safety and effectiveness of have not been established in pediatric patients less than 10 years old. *New dosage form.
|
|
|
P
|
|
|
Sun Pharmaceutical Industries
|
|
FALSE
|
Antidiabetic
|
09/10/2019
|
Aczone Gel
|
dapsone
|
Acne vulgaris
|
*Expanded the patient population to down to 9 years of age and older; previously approved down to 12 years. *Use in patients 9 to 11 years of age for this indication is supported by evidence from adequate and well-controlled clinical trials in 1066 patients 12 years and older and with additional pharmacokinetic and safety data in pediatric patients 9 to 11 years from an open label study of 100 patients with acne. *The adverse reactions in clinical trials was similar to the vehicle control group. *Safety and effectiveness have not been established in pediatric patients below 9 years of age. *Postmarketing study.
|
|
|
P
|
|
|
Almirall, LLC
|
|
FALSE
|
Antiacne, topical
|
09/10/2019
|
Gvoke
|
glucagon
|
Severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above
|
*Safety and effectiveness for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients ages 2 years and above. *Use for this indication is supported by evidence from a study in 31 pediatric patients ages 2 and older with type 1 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients younger than 2 years of age. *New dosage form. *Postmarketing study.
|
|
|
P
|
|
|
Xeris Pharmaceuticals, Inc.
|
|
FALSE
|
Antihypoglycemic
|
09/12/2019
|
Nucala
|
mepolizumab
|
Add-on maintenance treatment of patients with severe asthma, and with an eosinophilic phenotype to include patients aged 6 to 11 years
|
*Safety and efficacy for severe asthma, and with an eosinophilic phenotype, have been established in pediatric patients aged 6 years and older; previously approved down to 12 years and older. *Use in children 6 to 11 years with severe asthma, and with an eosinophilic phenotype, is supported by evidence from adequate and well-controlled trials in adults and adolescents with additional pharmacokinetic, pharmacodynamic, and safety data in children aged 6 to 11 years. A single, open-label clinical trial was conducted in 36 children aged 6 to 11 years with severe asthma. *Based upon the pharmacokinetic data from this trial, a dose of 40 mg SC every 4 weeks was determined to have similar exposure to adults and adolescents administered a dose of 100 mg SC. *Efficacy in children aged 6 to 11 years is extrapolated from efficacy in adults and adolescents with support from pharmacokinetic analyses showing similar drug exposure levels for 40 mg administered subcutaneously every 4 weeks in children aged 6 to 11 years compared with adults and adolescents. *The safety profile and pharmacodynamic response observed in this trial for children aged 6 to 11 years were similar to that seen in adults and adolescents. *Safety and efficacy in pediatric patients aged younger than 6 years with severe asthma have not been established. *Information on dosing, and PK parameters. *Postmarketing study.
|
|
|
P
|
|
|
GlaxoSmithKline
|
|
FALSE
|
Antiasthmatic
|
09/13/2019
|
Teflaro Injection
|
ceftaroline fosamil
|
Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) to include pediatric patients from birth to less than 2 months
|
*Safety and effectiveness in the treatment of ABSSSI have been established in pediatric patients (at least 34 weeks gestational age and 12 days postnatal age); previously approved down to 2 months. *Use of Teflaro in pediatric patients less than 2 months of age was supported by pharmacokinetic and safety data in 11 infants at least 34 weeks gestational age and 12 days postnatal age. *Safety and effectiveness in pediatric patients less than 34 weeks gestational age and less than 12 days postnatal age for the treatment of ABSSSI have not been established. *Adverse reactions were similar to those observed in adults. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study.
|
|
|
P
|
|
|
Allergan
|
|
FALSE
|
Antibiotic
|
09/13/2019
|
Mydayis
|
mixed salts of a single-entity amphetamine
|
Attention Deficit Hyperactivity Disorder (ADHD)
|
*Safety and effectiveness have not been established in pediatric patients ages 12 years and younger. *Mydayis has been studied for the treatment of ADHD in pediatric patients 6 to 12 years in two placebo-controlled safety and efficacy trials. *In the first trial, pediatric patients 6 to 12 years experienced higher rates of adverse reactions in some cases compared to patients 13 years and older, including higher rates of insomnia (30% versus 8%) and appetite decreased (43% versus 22%). *Amphetamine systemic exposures in pediatric patients 6 to 12 years following a single dose were higher than those observed in adults at the same dose (72-79% higher Cmax and approximately 83% higher AUC). A second trial evaluated a lower dose than those approved for pediatric patients 13 to 17 years; efficacy was not demonstrated for the lower dose. *A safe and effective dose cannot be established in pediatric patients 12 years and younger. *Information on adverse reactions, PK parameters, and clinical trials. *Postmarketing requirement.
|
|
|
|
B,P
|
|
Shire
|
08/18/2019
|
FALSE
|
CNS Stimulant
|
09/25/2019
|
Dysport
|
abobotulinumtoxinA
|
Treatment of upper limb spasticity in pediatric patients 2 years and older
|
*Approved for the treatment of upper limb spasticity in pediatric patients 2 years and older, excluding spasticity caused by cerebral palsy. *Safety and effectiveness have been established by evidence from adequate and well-controlled studies in patients 2 years and older with upper limb spasticity. *A pediatric study demonstrated that Dysport is safe and effective in another pediatric population. However, Dysport is not approved for such patient population due to marketing exclusivity for another botulinum toxin. *Safety and effectiveness in pediatric patients below the age of 2 years have not been established. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study.
|
|
|
P
|
|
|
Ipsen Biopharmaceuticals, Inc.
|
|
FALSE
|
Antispasmodic
|
09/26/2019
|
Mavyret
|
glecaprevir and pibrentasvir
|
Chronic hepatitis C virus infection (HCV) 12 years and older or weighing at least 45 kg
|
*The treatment duration for chronic HCV for treatment-naïve patients was changed from 12 weeks to 8 weeks. *The new 8-week treatment duration for genotypes (GTs) 1,2,3,4,5 and 6 for treatment-naïve patients with compensated cirrhosis with Chronic Hepatitis C Virus (HCV) infection is supported by the EXPEDITION-8 study. *Information on dosing, and clinical trial. *New dosing regimen. *Postmarketing study.
|
|
|
P
|
|
|
AbbVie Inc.
|
|
FALSE
|
Antiviral
|
10/01/2019
|
Entresto
|
sacubitril/valsartan
|
Treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older
|
*Safety and effectiveness in pediatric heart failure patients 1 to <18 years old are supported by the reduction from baseline to 12 weeks in NT-proBNP in a randomized, double-blind clinical study [see Clinical Studies (14.2)]. The analysis of NT-proBNP included 90 patients age 6 to 18 years and 20 patients age 1 to 6 years. *Safety and effectiveness have not been established in pediatric patients less than 1 year of age. *Adverse reactions were similar to those observed in adults. *Information on dosing, PK parameters, clinical trial, and preparation of oral solution. *New indication.
|
|
|
|
B,P
|
|
Novartis Pharmaceuticals Corporation
|
09/26/2019
|
FALSE
|
Heart failure
|
10/03/2019
|
Descovy
|
emtricitabine and tenofovir alafenamide
|
Pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection
|
*Safety and effectiveness for HIV-1 PrEP in at-risk adolescents weighing at least 35 kg, excluding individuals at risk from receptive vaginal sex, is supported by data from an adequate and well-controlled trial for HIV-1 PrEP in adults with additional data from safety and pharmacokinetic studies in previously conducted trials with the individual drug products, FTC and TAF, with EVG+COBI, in HIV-1 infected adults and pediatric subjects. *While using DESCOVY for HIV-1 PrEP, HIV-1 testing should be repeated at least every 3 months, and upon diagnosis of any other STIs. Previous studies in at-risk adolescents indicated waning adherence to a daily oral PrEP regimen once visits were switched from monthly to quarterly visits. Adolescents may therefore benefit from more frequent visits and counseling. *Safety and effectiveness for HIV-1 PrEP in pediatric patients less than 35 kg have not been established. *Information on dosing, adverse reactions, PK parameters, and clinical trial.
|
|
|
P
|
|
|
Gilead Sciences
|
|
FALSE
|
Antiviral
|
10/03/2019
|
Tybost
|
cobicistat
|
Co-administered with darunavir for treatment of HIV-1 infection in pediatric patients weighing at least 35 kg
|
*Use for this indication is supported by evidence from adequate and well-controlled studies in adults, and by pharmacokinetic, safety, and virologic data from an open-label trial in virologically suppressed, HIV-1 infected pediatric patients aged 12 years and older. *The safety in these patients through 48 weeks was similar to that in antiretroviral treatment-naïve adults. *Safety and effectiveness in combination with darunavir in pediatric patients weighing less than 40 kg have not been established. • Adverse reactions were similar to those observed in adults. *Information on dosing, PK parameters, clinical trial. *Postmarketing study.
|
|
|
|
B,P
|
|
Gilead Sciences
|
|
FALSE
|
Antiviral
|
10/04/2019
|
Aklief
|
trifarotene
|
Acne vulgaris
|
*Safety and effectiveness for the topical treatment of acne vulgaris have been established in pediatric patients age 9 years to 17 years based on evidence from well-controlled clinical trials, a long-term safety trial, and a pharmacokinetic trial. A total of 897 pediatric subjects aged 9 to 17 years received Aklief Cream in the clinical trials. *Safety and effectiveness have not been established in pediatric subjects under the age of 9 years. *Information on PK parameters and clinical trials.
|
|
|
P
|
|
|
Galderma
|
|
FALSE
|
Antiacne, topical
|
10/04/2019
|
Quzyttir
|
cetirizine hydrochloride
|
Treatment of acute urticaria in adults and children 6 months of age and older
|
*Safety and efficacy have been established in patients 6 months to 17 years of age. *Efficacy for the treatment of acute urticaria down to 6 months is based on extrapolation of the efficacy of Quzyttir in adults with acute urticaria and supported by pharmacokinetic data with oral cetirizine hydrochloride in patients 6 months to 17 years of age. *Based upon the known PK profile of oral cetirizine hydrochloride, the exposure of IV cetirizine hydrochloride in pediatric patients 6 months to 17 years is expected to be similar to the exposure of IV cetirizine hydrochloride in adults at the labeled doses. *Safety in children 6 months to 17 years of age is supported by safety information from placebo-controlled clinical trials with oral cetirizine hydrochloride in patients 6 months of age and older. *Quzyttir demonstrates a higher Cmax compared to oral cetirizine hydrochloride in adults. *Because of the absence of pharmacokinetic and safety information for cetirizine hydrochloride in children below 6 years with impaired renal or hepatic function, use in this impaired patient population is not recommended. *Safety and efficacy in patients less than 6 months of age has not been established. *Information on PK parameters and clinical trials. *New dosage form.
|
|
|
P
|
|
|
JDP Therapeutics Inc.
|
|
FALSE
|
Antihistamine, topical
|
10/10/2019
|
Wilate
|
von Willebrand Factor/Coagulation Factor VIII Complex (Human)*
|
Indicated in pediatric subjects and adults with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on-demand treatment and control of bleeding episodes
|
See Package Insert for new information on biologics
|
|
|
P
|
|
|
Octapharma Pharmazeutika Prod.Ges.m.b.
|
|
FALSE
|
Antihemophilic Factor
|
10/18/2019
|
Amzeeq
|
minocycline
|
Inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older
|
*Safety and effectiveness have been established in pediatric patients 9 years and older for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris. *Use for this indication is supported by three adequate and well-controlled 12-week trials in patients 9 years and older. A total of 686 patients 9 years and older received Amzeeq in these clinical trials. *Safety and effectiveness for this indication have not been established in pediatric patients less than 9 years. *The use of oral tetracycline drugs during tooth development below the age of 8 years may cause permanent discoloration of the teeth and inhibition of bone growth. *Information on PK parameters and clinical trials. *New dosage form.
|
|
|
P
|
|
|
Foamix Pharmaceuticals Inc.
|
|
FALSE
|
Antiacne, topical
|
10/18/2019
|
Botox
|
onabotulinumtoxinA
|
Treatment of lower limb spasticity in pediatric patients 2 to 17 years of age
|
*Safety and effectiveness have been established in pediatric patients 2 to 17 years. *Safety and effectiveness of have been established by evidence from adequate and well-controlled studies of Botox in patients 2 to 17 years with lower limb spasticity. However, treatment Botox for this indication is not intended to substitute for usual standard of care rehabilitation regimens. *A pediatric assessment for Botox demonstrated that it is safe and effective in another pediatric population. However, Botox is not approved for such patient population due to marketing exclusivity for another botulinum toxin. *Safety and effectiveness in pediatric patients below the age of 2 years have not been established. *Information on dosing, adverse reactions, and clinical trials. *Postmarketing study.
|
|
|
P
|
|
|
Allergan
|
|
FALSE
|
Neuromuscular blocking agent
|
10/18/2019
|
Ultomiris
|
ravulizumab-cwvz
|
Treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
|
*Safety and effectiveness for the treatment of aHUS have been established in pediatric patients aged one month and older. *Use for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic, safety, and efficacy data in pediatric patients aged 10 months to <17 years. *Safety and efficacy for the treatment of paroxysmal nocturnal hemoglobinuria in pediatric patients have not been established. *Information on dosing recommendations and considerations, adverse reactions, and clinical trial. *New indication.
|
|
|
P
|
|
|
Alexion Pharmaceuticals, Inc.
|
|
FALSE
|
Humanized monoclonal antibody
|
10/25/2019
|
Opana
|
oxymorphone HCl
|
Postoperative pain
|
*Safety and effectiveness for pediatric patients, 0 to 17 years, have not been established. *An open-label study was conducted in 58 pediatric patients 12 years and older with postoperative pain. Efficacy was not demonstrated in this population treated with doses expected to be comparable to effective starting doses in adults. *Pharmacokinetic results demonstrated that treatment with Opana tablets resulted in substantially higher systemic exposures to oxymorphone in 2 out of 24 patients. *Not recommended for use in the pediatric population. *Postmarketing study.
|
|
|
P
|
|
|
Endo
|
|
FALSE
|
Analgesic
|
11/05/2019
|
Sorilux
|
calcipotriene
|
Topical treatment of plaque psoriasis of the scalp and body in pediatric patients 4 years and older
|
*Expanded the indication down to patients 4 years of age and older; previously approved for use in 12 years and older. *Safety and effectiveness in pediatric patients less than 4 years have not been established. *Information on PK, and clinical trial. *Postmarketing study.
|
|
|
P
|
|
|
Mayne Pharma, Inc.
|
|
FALSE
|
Vitamin D analog
|
11/13/2019
|
Lumason
|
Sulfur Hexafluoride Lipid-Type A Microspheres
|
Use in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult and pediatric patients with suboptimal echocardiograms
|
*Safety and effectiveness have been established for use in pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve delineation of the left endocardial border. *Safety and effectiveness in pediatric patients are based on adequate and well-controlled studies in adults and are supported by a clinical study in 12 pediatric patients with extrapolation of efficacy to younger pediatric patients. *No new adverse reactions were reported in the pediatric study. *Safety of intravenous use of Lumason was based on evaluation of published literature involving the use of Lumason in over 1400 pediatric patients (0 to 17 years). *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study.
|
|
|
P
|
|
|
Bracco Diagnostics
|
|
|
Medical imaging
|
11/15/2019
|
Harvoni
|
ledipasvir and sofosbuvir
|
Treatment of chronic hepatitis C virus infection in patients with severe renal impairment including patients with end stage renal disease on dialysis
|
*In patients with severe renal impairment, including those requiring dialysis, exposures of the inactive metabolite of sofosbuvir are increased. *• No data are available regarding the safety of Harvoni in pediatric patients with renal impairment. *Postmarketing study.
|
|
|
P
|
|
|
Gilead Sciences
|
|
FALSE
|
Antiviral
|
12/04/2019
|
Latuda
|
lurasidone hydrochloride
|
Postmarketing study
|
*In a long-term, open-label study that enrolled pediatric patients age 6 to 17 years with schizophrenia, bipolar depression, or autistic disorder from three short-term, placebo-controlled trials, 54% (378/701) received lurasidone for 104 weeks. *In this trial, the mean increase in height from open-label baseline to Week 104 was 4.94 cm. The mean change in height z-score indicates a minimal deviation from the normal growth curve. *Postmarketing study.
|
|
|
P
|
|
|
Sunovion Pharmaceuticals, Inc.
|
|
FALSE
|
Antipsychotic
|
12/06/2019
|
Abraxane
|
paclitaxel
|
Recurrent or refractory pediatric solid tumors
|
*Safety and effectiveness in pediatric patients have not been established. *Pharmacokinetics, safety, and antitumor activity were assessed in an open-label, dose escalation, dose expansion study in 96 pediatric patients aged 1.4 to < 17 years with recurrent or refractory pediatric solid tumors. *The maximum tolerated dose (MTD) normalized for body surface area (BSA) was lower in pediatric patients compared to adults. *No new safety signals were observed in pediatric patients across these studies. *Paclitaxel protein-bound exposures normalized by dose were higher in 96 pediatric patients aged 1.4 to < 17 years as compared to those in adults.
|
|
B
|
|
|
|
Abraxis BioScience, L.L.C.
|
11/08/2019
|
FALSE
|
Antineoplastic
|
12/18/2019
|
Aralzo
|
tazarotene
|
Acne
|
*Safety and effectiveness for the topical treatment of acne vulgaris have been established in pediatric patients age 9 years and older based on evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled, 12-week clinical trials and an open-label pharmacokinetic study. *A total of 300 pediatric subjects aged 9 to less than 17 years received Arazlo in the clinical studies. *Safety and effectiveness in pediatric patients below the age of 9 years have not been established. *New dosage form.
|
|
|
P
|
|
|
Bausch Health US, LLC
|
|
FALSE
|
Antiacne, topical
|
12/19/2019
|
Conjupri
|
levamlodipine
|
Hypertension in adults and pediatric patients 6 years and older
|
*Indicated in patients 6 to 17 years. *Effect of levamlodipine on blood pressure in patients less than 6 years of age is not known. *Information on dosing, PK parameters, and clinical trials. *New active ingredient.
|
|
|
P
|
|
|
CSPC Ouyi Pharmaceutical Co., Ltd.
|
|
FALSE
|
Antihypertensive
|
12/19/2019
|
Fiasp
|
insulin aspart
|
Diabetes mellitus in pediatric patients
|
*Safety and effectiveness have been established to improve glycemic control in pediatric patients with diabetes mellitus. *Use for this indication is supported by evidence from an adequate and well-controlled study in 777 pediatric patients with type 1 diabetes mellitus aged 2 to 17 years, and from studies in adults with diabetes mellitus. *Pediatric patients with type 1 diabetes treated with mealtime and postmeal FIASP reported a higher rate of blood glucose confirmed hypoglycemic episodes compared to patients treated with NovoLog; the imbalance was greater during the nocturnal period. *Monitor blood glucose levels closely in pediatric patients. *Information on dosing, adverse reactions, PK parameters and clinical trials. *Postmarketing study.
|
|
|
P
|
|
|
Novo Nordisk, Inc.
|
|
FALSE
|
Antidiabetic
|
12/20/2019
|
Vibramycin, Vibra-Tabs
|
doxycycline monohydrate; doxycycline hyclate; doxycycline calcium; doxycycline hyclate
|
Postmarketing study
|
*Population pharmacokinetic analysis of sparse concentration-time data of doxycycline following standard of care intravenous and oral dosing in 44 pediatric patients 2-18 years showed that allometrically -scaled clearance (CL) of doxycycline in pediatric patients =2 to =8 years of age did not differ significantly from pediatric patients >8 to 18 years. *For pediatric patients weighing =45 kg, body weight normalized doxycycline CL in those =2 to =8 years did not differ significantly from those >8 to 18 years. * In pediatric patients weighing >45 kg, no clinically significant differences in body weight normalized doxycycline CL were observed between those =2 to =8 years and those >8 to 18 years of age. *No clinically significant difference in CL between oral and IV dosing was observed in the small cohort of pediatric patients who received the oral (N=19) or IV (N=2l) formulation alone. *Off-patent Written Request.
|
|
B
|
|
|
|
Pfizer, Inc.
|
|
FALSE
|
Antibiotic
|
12/20/2019
|
Mycamine
|
micafungin
|
Treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age
|
*Safety and effectiveness at a dose of 4 mg/kg once daily have been established in pediatric patients without meningoencephalitis and/or ocular dissemination younger than 4 months. *This use and dose are supported by evidence from adequate and well-controlled studies in adult and pediatric patients 4 months and older with additional pharmacokinetic and safety data in pediatric patients younger than 4 months of age. *Safety and effectiveness have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months as a higher dose may be needed. *Safety and effectiveness in pediatric patients younger than 4 months have not been established for (1) the treatment of esophageal candidiasis and (2) prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation. *Information on dosing, adverse reactions, PK parameters and clinical trials. *Postmarketing study.
|
|
|
P
|
|
|
Astellas
|
|
FALSE
|
Antiviral
|
01/24/2020
|
Dificid
|
fidaxomicin
|
Treatment of Clostridioides difficile-associated diarrhea (CDAD) in pediatric patients 6 months to 17 years
|
*Safety and effectiveness of the treatment of CDAD have been established in pediatric patients 6 months to 17 years. *Use of fidaxomicin in these age groups is supported by evidence from adequate and well-controlled trials of fidaxomicin in adults with CDAD and pharmacokinetic, safety and efficacy data from pediatric trials. *Adverse reactions are similar to those observed in adults. *Safety and effectiveness have not been established in pediatric patients younger than 6 months. *Information on dosing, Adverse Reactions, PK parameters and clinical trials. *New oral suspension. *Postmarketing study. *Summary pending.
|
|
B
|
|
|
|
Cubist Pharmaceuticals
|
12/13/2019
|
FALSE
|
|
01/31/2020
|
AUDENZ
|
Influenza A (H5N1) Monovalent Vaccine, Adjuvanted*
|
Active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine in persons 6 months and older
|
See Package Insert for new information on biologics
|
|
|
P
|
|
|
Seqirus, Inc.
|
|
FALSE
|
Preventive Vaccine
|
01/31/2020
|
Viibryd
|
vilazodone hydrochloride
|
Major depressive disorder (MDD)
|
*Safety and effectiveness have not been established in pediatric patients for the treatment of MDD. *Efficacy was not demonstrated in two adequate and well controlled, 8-week studies including a total of 1002 pediatric patients ages 7 years to 17 years of age with MDD. *The following adverse reactions were reported in at least 5% of pediatric patients treated with Viibryd and occurred at a rate at least twice that for pediatric patients receiving placebo: nausea, vomiting, diarrhea, abdominal pain/discomfort, and dizziness. *Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients.
|
|
|
|
B,P
|
|
3M Drug Delivery Systems Division
|
01/21/2020
|
FALSE
|
Antidepressant
|
01/31/2020
|
PALFORZIA
|
Peanut (Arachis hypogaea) Allergen Powder-dnfp*
|
Mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years and older
|
See Package Insert for new information on biologics
|
|
|
P
|
|
|
Aimmune Therapeutics, Inc.
|
|
FALSE
|
Allergenic extract
|
02/12/2020
|
Doryx; Doryx MPC
|
doxycycline hyclate
|
Postmarketing study
|
*Population pharmacokinetic analysis of sparse concentration-time data of doxycycline following standard of care intravenous and oral dosing in 44 children (2-18 years of age) showed that allometrically-scaled clearance of doxycycline in children =2 to =8 years did not differ significantly from children >8 to 18 years. *No clinically significant difference in CL differences between oral and IV were observed in the small cohort of pediatric patients who received the oral (N=l9) or IV (N=21) formulation alone. *Off-patent written request.
|
|
B
|
|
|
|
Mayne Pharma International
|
|
FALSE
|
Antibiotic
|
03/02/2020
|
Cafcit Injection
|
caffeine citrate
|
Postmarketing study
|
*Expanded indication to include a broader gestational age (GA) range of premature infants. The lower and upper GA limits were removed from the Indications and Usage; previously indicated for the short-term use in infants between 28 - <32 weeks gestational age. *The term "short-term" was removed from the Indications and Usage section allowing for a longer treatment duration. *In a published randomized, placebo-controlled, clinical trial that studied the use of caffeine citrate in apnea of prematurity in approximately 2000 patients, necrotizing enterocolitis was not more common in caffeine treated patients compared to placebo. *Information on dosing, adverse reactions, and clinical trial. *Off-patent Written Request.
|
|
B
|
|
|
|
Hikma Pharmaceuticals International Limited
|
|
FALSE
|
Bronchial smooth muscle relaxant
|
03/04/2020
|
Cleocin Phosphate
|
clindamycin injection; clindamycin injection in dextrose
|
Postmarketing study
|
*The following statement was added to Dosage and Administration section: Clindamycin should be dosed on total body weight regardless of body weight. *Obese Pediatric Patients Aged 2 to Less than 18 Years and Obese Adults Aged 18 to 20 Years: An analysis of pharmacokinetic data in obese pediatric patients aged 2 to less than 18 years and obese adults aged 18 to 20 years demonstrated that clindamycin clearance and volume of distribution, normalized by total body weight, are comparable regardless of obesity. *Off-patent Written Request.
|
|
B
|
|
|
|
Pfizer, Inc.
|
|
FALSE
|
Antibiotic
|
03/04/2020
|
Acticlate; Acticlate Cap
|
doxycycline hyclate
|
Postmarketing study
|
*Population pharmacokinetic analysis of sparse concentration-time data of doxycycline following standard of care intravenous and oral dosing in 44 children (2-18 years) showed that allometrically-scaled clearance of doxycycline in children =2 to =8 years did not differ significantly from children >8 to 18 years. *No clinically significant difference in CL differences between oral and IV were observed in the small cohort of pediatric patients who received the oral (N=19) or IV (N=21) formulation alone. *Off-patent written request.
|
|
B
|
|
|
|
Almirall, LLC
|
|
FALSE
|
Antibiotic
|
03/19/2020
|
Epclusa
|
Sofosbuvir/velpatasvir
|
Treatment of chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection in pediatric patients 6 years of age and older or weighing at least 17 kg
|
*The pharmacokinetics, safety, and effectiveness have been established in an open-label, multicenter clinical trial. *Safety and effectiveness for treatment of HCV genotype 5 in pediatric patients 6 years and older or weighing at least 17 kg without cirrhosis or with compensated cirrhosis are supported by sofosbuvir, GS-331007, and velpatasvir exposures in adults and pediatric patients. *In patients with severe renal impairment, including those requiring dialysis, exposures of GS-331007, the inactive metabolite of sofosbuvir, are increased. *No data are available regarding the safety in pediatric patients with renal impairment. *Safety and effectiveness have not been established in pediatric patients less than 6 years. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *New 200 mg/50 mg strength tablet.
|
|
|
P
|
|
|
Gilead Sciences, Inc.
|
|
FALSE
|
Antiviral
|
03/23/2020
|
Eucrisa ointment
|
crisaborole
|
Mild to moderate atopic dermatitis in patients 3 months to less than 2 years
|
*Safety and effectiveness have been established in pediatric patients 3 months and older for topical treatment of mild to moderate atopic dermatitis. *Use in this age group is supported by data from two 28-day, vehicle-controlled safety and efficacy trials which included 1,313 pediatric patients ages 2 years to 17 years whom received Eucrisa. *Use in pediatric patients ages 3 months to less than 2 years was supported by data from a 28-day open-label, safety and pharmacokinetics (PK) trial in 137 patients. *Safety and effectiveness in pediatric patients below the age of 3 months have not been established. *No new safety signals were identified in patients 3 months to less than 2 years. *Information on adverse reactions, PK parameters, and clinical studies. *Postmarketing study.
|
|
B,P
|
|
|
|
Anacor Pharmaceuticals, Inc.
|
02/21/2020
|
FALSE
|
Phosphodiesterase 4 inhibitor
|
03/26/2020
|
Taltz
|
ixekizumab
|
Moderate-to-severe plaque psoriasis
|
*Safety and effectiveness have been established in pediatric patients 6 years to less than 18 years with moderate-to-severe plaque psoriasis. *Safety and effectiveness in other pediatric indications and for pediatric patients less than 6 years of age have not been established. *In the clinical trial, Crohn's disease occurred at a greater frequency in the treatment group (0.9%) than the placebo group (0%) during the 12-week, placebo-controlled period. Crohn's disease occurred in a total of 4 Talkz treated patients (2.0%) in the clinical trial. *Safety profile was similar to those observed in adults with plaque psoriasis with the exception of the frequencies of conjunctivitis (2.6%), influenza (1.7%), and urticaria (1.7%). *Information on dosing, adverse reactions, PK parameters and clinical trial. *Postmarketing study.
|
|
|
P
|
|
|
Eli Lilly
|
|
FALSE
|
Humanized interleukin-17A antagonist
|
04/20/2020
|
Cymbalta
|
duloxetine
|
Fibromyalgia in pediatric patients 13 to 17 years
|
Label Change Summary - Use for treatment of fibromyalgia in patients 13 to 17 years of age is supported by a 13-week placebo-controlled trial in 184 patients with juvenile fibromyalgia syndrome. - Cymbalta showed improvement over placebo on the primary endpoint, change from baseline to end-of-treatment on the Brief Pain Inventory (BPI) – Modified Short Form: Adolescent Version 24-hour average pain severity rating. - Safety and effectiveness for the treatment of fibromyalgia in patients less than 13 years of age have not been established. - Information on dosing, adverse reactions, and clinical trial. - Postmarketing study.
|
*Use for treatment of fibromyalgia in patients 13 to 17 years of age is supported by a 13-week placebo-controlled trial in 184 patients with juvenile fibromyalgia syndrome. *Cymbalta showed improvement over placebo on the primary endpoint, change from baseline to end-of-treatment on the Brief Pain Inventory (BPI) *Modified Short Form: Adolescent Version 24-hour average pain severity rating. *Safety and effectiveness for the treatment of fibromyalgia in patients less than 13 years of age have not been established. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study.
|
|
P
|
|
|
Eli Lilly
|
|
FALSE
|
Antidepressant
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|