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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 585
n = 535 with New Pediatric Studies; n = 50 with No New Pediatric Studies
BPCA only = 166; BPCA + PREA = 80; PREA only = 289; Rule = 49; None = 1

Pediatric Labeling Changes as of July 31, 2015

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:  585
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
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 Antiulcerative
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 CNS Stimulant
05/10/2002 QVAR beclomethasone dipropionate Maintenance treatment of asthma as prophylactic therapy Summary is pending Antiasthmatic
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) Antiacne
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 Decongestant; anti-inflammatory
04/01/2002 Videx didanosine HIV infection Safety and effectiveness established down to 2 weeks Antiviral
03/29/2002 Zerit stavudine HIV infection Safety and effectiveness established down to birth Established a dose for newborns from birth to 13 days Antiviral
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 Antilipemic
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 Anti-inflammatory
02/08/2002 Clarinex Tablets desloratadine Relief of pruritis/hives in patients with chronic idiopathic urticaria Approved down to 12 years of age Antihistamine
02/08/2002 Clarinex Tablets desloratadine Perennial allergic rhinitis Approved down to 12 years of age Antihistamine
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 Antiasthmatic
01/25/2002 Daypro oxaprozin Relief of signs and symptoms of Juvenile Rheumatoid Arthritis New indication in 6 years -16 years Anti-inflammatory
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 Antiviral
12/21/2001 Clarinex Tablets desloratadine Seasonal allergic rhinitis Approved down to 12 years of age Antihistamine
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%) Ophthalmologic hypotensive
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. Immunomodulator
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 Summary 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

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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. Note: Drugs with *** had a pediatric labeling change in response to BPCA after the Written Request expired.

Helpful Links:
Drug and therapeutic biological labeling:

Biological labeling and reviews:

BPCA 2002 Review Summaries:

**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.