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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 500
n = 453 with New Pediatric Studies; n = 47 with No New Pediatric Studies
BPCA only = 157; BPCA + PREA = 66; PREA only = 228; Rule = 48; None = 1

Pediatric Labeling Changes as of September 30, 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:  500
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
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
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) Analgesic; Antipyretic
12/08/1999 Alocril nedocromil Allergic Conjunctivitis * Approved down to 3 years of age Antihistamine, topical
11/08/1999 Omnicef cefdinir Bronchitis * Approved for use in adolescents Antibiotic
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 Antiulcerative
09/24/1999 Alamast pemirolast Allergic Conjunctivitis * Safety and effectiveness established down to 3 years Antihistamine, topical
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 Antiasthmatic
08/24/1999 Ceftin Oral Suspension cefuroxime Acute bacterial sinusitis * Approved down to 3 years of age Antibiotic
08/18/1999 Derma-Smoothe/FS Topical Oil fluocinolone Atopic dermatitis * Approved down to 6 years of age; previously approved in adults only Anti-inflammatory, topical
07/26/1999 Relenza Rotadisk zanamivir Treatment of influenza A and B * New indication approved down to 12 years of age Antiviral
07/23/1999 Topamax Tablets topiramate Adjunctive treatment of partial onset seizures and generalized tonic clonic seizures * Approved down to 2 years of age Anticonvulsant
07/14/1999 Omnicef cefdinir Otitis media * Approved 5-day treatment regimen; previously labeled for a 5-10 day treatment regimen Antibiotic
07/09/1999 Tagamet HB 200 Liquid OTC cimetidine Heartburn and indigestion * New indication approved down to 12 years of age; new OTC suspension Antiulcerative
07/02/1999 Zaditor Ophthalmic Soln. ketotifen fumarate Allergic conjunctivitis * Approved down to 3 years of age; efficacy extrapolated from adult data Antihistamine, topical
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 Anti-inflammatory, topical
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) Analgesic; Antipyretic
12/17/1998 Ziagen abacavir HIV infection * Labeling for 3 months - 12 years * Information on dose, efficacy, PK parameters and AE profile Antiviral
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 Hypnotic
02/10/1998 Amerge naratriptan Migraine *Su mmary is pending Antimigraine

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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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