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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 523
n = 474 with New Pediatric Studies; n = 49 with No New Pediatric Studies
BPCA only = 158; BPCA + PREA = 70; PREA only = 244; Rule = 50; None = 1

Pediatric Labeling Changes as of July 15, 2014

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:  523
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
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 established* A 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. Platelet inhibitor
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 patients* Effectiveness has not been established in patients less than 1 month of age* Information on dosing, adverse reactions, pharmacokinetics and clinical trial* Postmarketing study 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 recommended* Information on postmarketing clinical trial, adverse reactions* Postmarketing PREA required study Antiemetic
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 AEDs* Information on conversion to monotherapy, adverse reactions, clinical trial* New indication Anticonvulsant
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 Preventive Vaccine
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 older* Safety and effectiveness in pediatric patients with conditions other than SJIA have not been established* Children < 2 years have not been studied* Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia* Liver 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 diarhea* Information on dosing, lab parameters, adverse reactions, clinical trial* New indication Biological response modifier
04/06/2011 Invega paliperidone Treatment of schizophrenia * Extended treatment of schizophrenia indication from adults to adolescents 12-17 years* Safety 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-related* In 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 studies* Adverse reactions in the adolescent trial included somnolence, akathisia, tremor, dystonia, cogwheel rigidity, anxiety, weight gain, and tachycardia* Information on dosing, adverse events, clinical trial Antipsychotic
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 demonstrated* No responses were observed among the 72 patients in the Phase 2 trial* Information on dosing, clinical trial, adverse events and pharmacokinetics Antineoplastic
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 years* Safety and effectiveness have not been established in children <2 years* Information on dosing, adverse events, pharmacokinetics, and clinical trials Medical imaging
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 older* Information on adverse reactions and clinical trial* New indicatio Non-stimulant ADHD treatment
02/17/2011 Hizentra Globulin Subcutaneous (Human), 20% Liquid * Postmarketing study See Package Insert for new information on biologics Immune Serum
02/03/2011 Makena hydroxyprogesterone caproate Reduce the risk of preterm birth * Safety and effectiveness in pediatric patients <16 years have not been established* A 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 older* Information on clinical trial Progestin
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 Preventive Vaccine
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 established* A 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 adults* Information on clinical tria Anti-inflammatory, topical
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 absorption* Natroba 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 toxicity* Information on clinical trials, adverse reactions* New drug Pediculocide, topical
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 Preventive Vaccine
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 Pulmonary vasodilator
12/15/2010 Uroxatral alfuzosin Elevated detrusor leak point pressure of neurologic origin * Uroxatral is not indicated for use in the pediatric population* Efficacy 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 Urology
11/19/2010 Moxeza Ophthalmic Solution moxifloxacin Bacterial conjunctivitis * Approved for use in patients 4 months and older* The 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 animals* Information on clinical study, adverse reactions* New dosage form Antibiotic
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 Antibiotic
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 weight* Information on clinical trial, adverse reactions CNS Stimulant
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 older* Most common adverse reactions in pediatric patients were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.* Information on dosing, clinical studies, adverse reactions and PK parameters* New dosage form and route of administration Analgesic; Antipyretic
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

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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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