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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database
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N = 467
n = 425 with New Pediatric Studies; n = 42 with No New Pediatric Studies
BPCA only = 153; BPCA + PREA = 62; PREA only = 203; Rule = 48; None = 1

Pediatric Labeling Changes as of February 26, 2013

This list highlights key pediatric information from the studies submitted in response to pediatric legislative initiatives. CBER regulated products have an asterisk (*) by the proper name. To obtain all the information for a pediatric labeling change, select the pediatric labeling date in the first column of the database to reveal the additional information. To view all records in the database, select the All button at the bottom of the page. To search for a specific pediatric labeling change, enter the trade name or generic name in the Filter box and select Show Items. Note: CBER and CDER regulated biologics with pediatric labeling changes before 9/27/2007 are excluded from the database.

Download New Pediatric Labeling Information Database data in Microsoft Excel web format Click on this link to download all data from the selected searchable database in Excel format. If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.


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   No. of Records Found:  468
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
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 Vitamin
11/13/2001 Focalin dexmethylphenidate Attention Deficit Hyperactivity Disorder Pending CNS Stimulant
10/10/2001 Derma-Smoothe/FS Topical Oil fluocinolone Atopic dermatitis * Approved down to 2 years of age Anti-inflammatory, topical
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 Anti-inflammatory, topical
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 Antiarrhythmic
08/28/2001 Topamax Tablets and Sprinkle Capsules topiramate Seizures associated with Lennox-Gastaut syndrome * Approved for treatment down to 2 years of age Anticonvulsant
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) 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 Antianxiety
06/25/2001 Valtrex Caplets valacyclovir Treatment of cold sores * New indication approved for use down to 12 years of age Antiviral
06/06/2001 Mentax Cream butenafine Tinea versicolor * Approved down to 12 years of age; previously approved in adults only Antifungal, topical
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 Antiviral
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 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 Antiasthmatic
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 Anesthetic agent
02/21/2001 Infuvite Pediatric multivitamin infusion Daily multivitamin maintenance * Approved for infants down to newborn Vitamin
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 Antihypertensive
12/21/2000 Benzaclin benzoyl peroxide; clindamycin phosphate Acne vulgaris * Approved down to 12 years of age Antiacne, topical
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 Immunosuppressant
12/15/2000 Glucophage (immediate release) metformin Diabetes Mellitus * Safety and effectiveness as monotherapy established in patients 10-16 years of age Antidiabetic
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 Antiviral
12/11/2000 Maxalt and Maxalt-MLT rizatriptan Migraine *Su mmary is pending Antimigraine
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 Immunomodulator
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 Antihistamine
11/27/2000 Benzamycin Pak erythromycin-benzoyl peroxide Acne vulgaris * Approved down to 12 years of age Antiacne, topical
11/27/2000 Clindagel clindamycin topical gel Acne vulgaris * Approved down to 12 years of age Antiacne, topical
11/17/2000 Tamiflu Capsule oseltamivir Prophylaxis of influenza A and B * Approved for prophylactic use down to 13 years of age Antiviral
11/14/2000 Trizivir Tablets abacavir, lamivudine, zidovudine HIV * Approved in adults and adolescents weighing e 40kg Antiviral
10/27/2000 Atrovent Nasal Spray ipratropium Rhinorrhea * Approved down to 5 years of age Antihistamine
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 Anticonvulsant
09/29/2000 Flovent Diskus Inhalation Powder fluticasone Asthma * Approved down to 4 years of age; new delivery system 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 Antipsychotic
09/15/2000 QVAR beclomethasone dipropionate Maintenance treatment of asthma as prophylactic thrapy for asthma patients who require systemic corticosteroid administration Summary is pending 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 Moisturizer
08/24/2000 Advair Diskus fluticasone/ salmeterol Asthma * Approved down to 12 years of age Antiasthmatic
08/21/2000 Unithroid Tablets levothyroxine Hypothyroidism * Approved down to the newborn Thyroid replacement
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 Anti-inflammatory
08/01/2000 Concerta Extended Release Tablets methylphenidate ADHD * Efficacy established down to 6 years of age CNS Stimulant
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 Decongestant; anti-inflammatory
07/27/2000 Vaniqa Cream eflornithine Reduction of facial hair in females * Approved for female patients down to 12 years of age Hair removal
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 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 Antimalarial
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 Infectious disease (non-viral)
05/26/2000 Differin Cream adapalene Acne vulgaris * Approved down to 12 years of age Antiacne, topical
05/22/2000 Optivar azelastine Itching associated with Allergic Conjunctivitis * Safety and effectiveness established down to 3 years Antihistamine, topical
04/26/2000 Relenza Rotadisk zanamivir Treatment of Influenza A and B * Approved down to 7 years of age Antiviral
04/20/2000 Lantus insulin glargine Type 1 Diabetes * Safety and effectiveness established down to 6 years Antidiabetic
04/12/2000 Trivagizole 3 Vaginal Cream clotrimazole Vaginal yeast infection * Approved for OTC use in patients 12 years of age and older 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 Antidiabetic
03/17/2000 Lamisil AT Spray Pump terbinafine Jock itch, athletes foot, ringworm * Approved for OTC use Antifungal, topical
02/04/2000 Tri-Nasal Spray triamcinolone Allergic rhinitis * Approved down to 12 years of age Anti-inflammatory, topical

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Products in this table are listed by labeling change date in descending order and fell within the scope of the Pediatric Rule, the Best Pharmaceuticals for Children Act (BPCA), and the Pediatric Research Equity Act (PREA), and contain new pediatric information. All other labeling changes are based on information from clinical trials in pediatric patients. This list only serves to highlight key information affecting the pediatric population at the time the particular application was approved resulting from the studies performed for the Pediatric Rule, BPCA and PREA.

Helpful Links:
Drug and therapeutic biological labeling:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Biological labeling and reviews:
http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm122938.htm

BPCA 2002 Review Summaries:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm161894.htm

**The Protopam labeling change is an exception. The labeling change is included in the Pediatric Labeling Changes Table even though it was not triggered by BPCA or PREA.

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