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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
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 age* Most common adverse reactions (incidence e30%) were stomatitis, upper respiratory tract infection, sinusitis, otitis media, and pyrexia* Dose 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 Antineoplastic
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 indicated* New dose and dosing regimen Contraceptive
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 older* Efficacy assessed in a total of 246 children and adolescents 6 to 17 years in 2 clinical trials* Bronchial challenge testing should not be performed in children < 6 years due to their inability to provide reliable spirometric measurements * Adverse events similar to adults* Information on adverse events and clinical studies* New indication, dosage form, and route of administration Diagnostic aid
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 older* Efficacy is based on 2 clinical trials in children and adolescents 6 -17 years * Kapvay has not been studied in children with ADHD < 6 years* Kapvay can cause dose related decreases in blood pressure and heart rate* Common 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 formulation* Information on adverse events, and clinical trials*New indication Non-stimulant ADHD treatment
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 Contraceptive
09/08/2010 Protopam** pralidoxime Treatment of poisoning due to organophosphates (e.g., nerve agents) * Expanded indication from adults to pediatrics * Efficacy extrapolated from adult population and supported by nonclinical studies, PK studies in adults and experience in the pediatric population * Information on IV and IM dosing, and adverse events Antidote
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 Antibiotic
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 Contraceptive
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 Antihistamine, topical
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 CNS Stimulant
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. Antiasthmatic
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 Antiasthmatic
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 Ophthalmologic hypotensive
06/03/2010 Zylet loteprednol etabonate and tobramycin Eye lid inflammation *Efficacy was not demonstrated in a study of pediatric patients 0-6 years Anti-inflammatory, 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 Anti-inflammatory, topical
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 Antibiotic
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 Antineoplastic
05/07/2010 Omnaris Nasal Spray ciclesonide Postmarketing study * Information on clinical study to assess effect of orally inhaled ciclesonide on growth Antiasthmatic; antiallergy
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 Contaceptive
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 Pancreatic enzyme
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 Antiviral
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 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 Diagnostic aid
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 Preventive Vaccine
02/22/2010 TamiFlu oseltamivir Prophylaxis of influenza * Information on postmarketing clinical study in patients 1 to 12 years Antiviral
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 Preventive Vaccine
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 Antihypertensive
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 Anticonvulsant
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 Endocrine agent
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 Antiasthmatic
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 Antiviral
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 Urology
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 Anticonvulsant
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 Anticonvulsant
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 CNS Stimulant
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 Antipsychotic
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 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 Antihistamine
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 Antipsychotic
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 Antiulcerative
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 Preventive Vaccine
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 Antiviral
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) CNS Stimulant
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 Antihypertensive
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 Preventive Vaccine
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 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 Preventive Vaccine
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 Antilipemic
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 Antilipemic
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 Contaceptive

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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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