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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 558
n = 508 with New Pediatric Studies; n = 50 with No New Pediatric Studies
BPCA only = 162; BPCA + PREA = 76; PREA only = 270; Rule = 49; None = 1

Pediatric Labeling Changes as of March 26, 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:  558
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
06/14/2012 MENHIBRIX Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine* Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b See Package Insert for new information on biologics Preventive Vaccine
05/30/2012 Torisel temsirolimus Advanced recurrent/refractory solid tumors * Effectiveness in pediatric patients has not been established * Torisel was studied in 59 patients 1 - 17 years and 12 patients 18 to 21 years in a phase 1-2 safety and exploratory pharmacodynamic study * Adverse reactions were similar to those observedd in adults * Information on dosing, clinical trials and PK parameters Antineoplastic
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions * Safety and efficacy assessed in a clinical trial that included 10 patients 8 - 17 years *Safety and efficacy of pancreatic enzyme products with different formulations of the same active ingredient for use in children have been described in medical literature and through clinical experience * Use in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended *High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age *Capsule should be swallowed whole. Capsule and contents should not be crushed or chewed *For patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce and swallowed immediately * Not interchangeable with other pancrelipase products *New drug Pancreatic enzyme
05/12/2012 Voluven 6% Hydroxyethyl Starch 130/0.4 In 0.9% Sodium Chloride Injection* Plasma volume substitute for treatment and prophylaxis of hypovolemia See Package Insert for new information on biologics Coagulant
05/01/2012 Dymista azelastine hydrochloride and fluticasone proprionate Relief of symptoms of seasonal allergic rhinitis *Safety and effectiveness have been established in 3 clinical trials in patients 12 years and older *Safety and effectiveness in pediatric patients < 12 years have not been established *Intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. The growth of pediatric patients receiving intranasal corticosteroids, including Dymista, should be monitored routinely *Information on dosing, adverse reactions, and clinical trials *New drug Antiasthmatic;antiallergy
04/27/2012 Lexiva fosamprenavir Treatment of HIV-1 infection * Expanded indication to include pediatric patients at least 4 weeks - <2 years; previously approved for use in 2  18 years *The PK, safety, tolerability, and efficacy in pediatric patients < 4 weeks have not been established *Dosing of Lexiva plus ritonavir is not recommended for protease inhibitor-experienced pediatric patients <6 months of age; data do not support twice-daily dosing of Lexiva without ritonavir in pediatric patients <2 years *Weight-adjusted apparent clearance was higher in children < 4 years, suggesting that younger children require higher mg per kg dosing of Lexiva *Vomiting and neutropenia were more frequent in pediatrics than in adults. Other adverse reactions were similar to adults * Information on dosing, clinical trials, PK and adverse reactions *New dosage regimen for patients at least 4 weeks - < 6 years; Postmarketing study Antiviral
04/27/2012 Levaquin levofloxacin Treatment and prophylaxis of plague due to Yersinia pestis * Approved for the treatment and prophylaxis of plague due to Yersinia pestis in patients 6 months and older *Efficacy studies could not be conducted in humans with pneumonic plague for ethical and feasibility reasons. Approval of this indication was based on an efficacy study conducted in animals *Safety and effectiveness in pediatric patients < 6 months have not been established *Information on animal study *New indication Antibiotic
03/26/2012 Singulair Oral Granules, Tablets, and Chewable Tablets montelukast Prevention of exercise-induced bronchoconstriction * Expanded indication to include pediatric patients from 6 - 14 years; previously approved for use in 15 years and older *Efficacy for prevention of EIB in patients < 6 years of age has not been established * Information on clinical trial, and dosing * Postmarketing study Antiasthmatic; antiallergy
03/26/2012 Intelence etravirine Treatment of HIV-1 infection in treatment-experienced patients in combination with other antiretroviral agents * Expanded the indication from adults to pediatric patients 6 years and older * Safety and efficacy have not been established in children < 6 years or in treatment naive adult or pediatric patients *Adverse reactions were similar to those observed in adults except for rash which was observed more frequently in pediatric patients (15%) compared to adults (10%)*Intelence tablet(s) should be swallowed whole. Patients who are unable to swallow the Intelence tablet(s) whole may disperse the tablet(s) in a glass of water *Information on dosing in pediatric patients 6 - <18 years and weighing at least 16 kg, dispersing tablet in water, adverse reactions, and clinical trial *Postmarketing study Antiviral
03/23/2012 QNASL beclomethasone dipropionate Treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis "Safety and effectiveness in children 12 years and older have been established "Safety and effectiveness in <12 years have not been established "Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Routinely monitor the growth of pediatric patients receiving QNASL Nasal Aerosol "The potential for QNASL Nasal Aerosol to cause reduction in growth velocity in susceptible patients or when given at higher than recommended dosages cannot be ruled out "Information on safety, adverse events and clinical trials "New dosage form Anti-inflammatory, topical
03/14/2012 Natazia estradiol valerate and estradiol valerate/dienogest Treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception "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 indication Contraceptive
03/01/2012 Ultresa pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions "Safety and efficacy assessed in 2 studies that included patients 7--17 years "Safety and efficacy of pancreatic enzyme products with different formulations of the same active ingredient for use in children have been described in medical literature and through clinical experience "High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age " Adverse reactions similar to adults "Use in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended "Children > 12 months and < 4 years, weighing < 14 kg and children e 4 years, weighing < 28 kg should not be dosed with this product because capsule dosage strengths cannot adequately provide dosing for these children "Capsule should be swallowed whole. Capsule and contents should not be crushed or chewed. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce and swallowed immediately "Information on dosing and clinical studies "Not interchangeable with other pancrelipase products "New drug Pancreatic enzyme
02/29/2012 FluMist Quadrivalent Influenza Vaccine Live, Intranasal* Active immunization for the prevention of disease caused by influenza See Package Insert for new information on biologics Vaccine
02/09/2012 Famvir famciclovir Recurrent herpes labialis "Efficacy has not been established in pediatric patients for the treatment of recurrent herpes labialis "Information on an open label PK, safety and efficacy study in children 12 to <18 years with recurrent herpes labialis added to Pediatric Use subsection of labeling"Postmarketing study Antiviral
02/07/2012 Sklice ivermectin Topical treatment of head lice infestations "Safety and effectiveness in children 6 months and older have been established "Safety has not been established in pediatric patients < 6 months. Sklice Lotion is not recommended in pediatric patients <6 months of age because of the potential increased systemic absorption and risk of ivermectin toxicity" Information on dosage and administration, adverse reactions, pharmacokinetics and clinical trials"New drug Pediculocide, topical
01/25/2012 TISSEEL Fibrin Sealant* Hemostasis: An adjunct to hemostasis in patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: An adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies See Package Insert for new information on biologics Wound healing
01/18/2012 Viread tenofovir disoproxil fumarate Treatment of HIV infection in combination with other antiretroviral agents *Viread tablets: Expanded the indication from adults to pediatric patients 2 - < 12 years, weighing greater than or equal to 17 kg, who can swallow an intact tablet; tablet previously approved for use in 12 years and older * Viread Oral Powder: Expanded the indication from adults to pediatric patients 2 years of age and older * Safety and effectiveness in patients <2 years have not been established *Viread oral powder should be mixed in a container of soft food not requiring chewing (e.g., applesauce, baby food, yogurt) and ingested immediately to avoid a bitter taste *Adverse reactions were similar to those observed in adults *Postmarketing study, new dosage form Antiviral
12/21/2011 Isentress raltegravir In combination with other antiretroviral agents for the treatment of HIV-1 infection *Isentress Chewable tablets: Expanded indication from adults to pediatric patients 2 - < 12 years and weighing at least 10kg *Isentress Tablets: Expanded indication from adults to pediatric patients 6-18 years *Safety and effectiveness in patients <2 years have not been established*Because the formulations are not bioequivalent, do not substitute chewable tablets for the 400 mg film-coated tablet *Safety profile similar to that observed in adults *Information on dosing, adverse reactions, clinical trial and PK parameters *New dosage form Antiviral
12/16/2011 Keppra levetiracetam Adjunctive therapy in the treatment of partial onset seizures * Expanded indication to include pediatric patients from 1 month - <4 years; previously approved for use in 4 years and older* In pediatric patients 1 month - < 4 years of age, 17% experienced psychotic symptoms compared to 5% on placebo; irritability was reported in 11.7% of the Keppra-treated patients compared to 0% of placebo patients* Information on dosing, clinical trial, adverse reactions Anticonvulsant
12/16/2011 Maxalt and Maxalt-MLT rizatriptan Treatment of migraine * Expanded indication to include pediatric patients from 6 - 17 years. Safety and effectiveness in this age group was established in an adequate and well-controlled trial.* Safety and effectiveness in pediatric patients under 6 years of age have not been established.* Efficacy and safety of treatment with more than one dose of Maxalt within 24 hours in patients 6 to 17 years of age have not been established* Maxalt should not be prescribed to propranolol-treated pediatric patients who weigh < 40 kg (88 lb)* The incidence of adverse reactions in the pediatric clinical trial was similar between treatment and placebo groups. The adverse reaction pattern in pediatric patients is expected to be similar to adults* Hallucination, abnormal coordination, disturbance in attention, and presyncope occurred infrequently in pediatric patients in the clinical trial * Information on dosing, adverse reactions, clinical trial, and overdose Antimigraine
12/16/2011 Prezista darunavir Treatment of HIV-1 infection in adults and pediatric patients 3 years of age and older and weighing at least 10 kg * Expanded indication to pediatric patients 3 years and older weighing at least 10 kg; previously approved for use in 6 years and older* Do not use in pediatric patients < 3 years of age* Information on dosing, adverse reactions, pharmacokinetics and clinical trial* New formulation Antiviral
12/15/2011 Nexium esomeprazole Erosive esophagitis due to acid-mediated gastroesophageal reflux disease * Expanded age range to include pediatric patients 1 month to <1 year. Previously approved in 1-17 years. Use in 1 month to <1 year is supported by extrapolation of studies for adults and safety, pharmacokinetic, and pharmacodynamic studies performed in pediatric patients * Safety and effectiveness have not been established in neonates* Information on weight-based dosing, adverse reactions, clinical study Antiulcerative
12/14/2011 Advate Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method* Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with hemophilia A See Package Insert for new information on biologics Antihemophilic Factor
11/10/2011 HEMACORD hematopoietic progenitor cells, cord blood* For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment See Package Insert for new information on biologics Somatic Cell
11/09/2011 Chantix varenicline Smoking cessation * Safety and effectiveness of Chantix in pediatric patients have not been established; Chantix is not recommended for use in patients < 18 years of age* Information on single and multiple-dose pharmacokinetics of varenicline have been investigated in pediatric patients 12 - 17 years * Postmarketing study Smoking cessation
10/18/2011 Ixempra Kit ixabepilone Advanced or refractory solid tumors * The effectiveness in pediatric patients has not been established * Ixempra was evaluated in one Phase 1 and one Phase 2 trial * Adverse reactions were similar to adults, and no new safety signals were identified Antineoplastic
10/17/2011 Reyataz atazanavir Treatment of HIV - 1 infection * Revised pediatric dosing; Unified dosing for treatment-naive and treatment experienced patients and extended the use of ATV/RTV to treatment-experienced patients weighing 15 to 25 kg* New dosing regimen Antiviral
08/22/2011 Copegus and PEGASYS ribavirin and peginterferon alfa-2a Treatment of chronic hepatitis C in patients 5 to 17 years of age * Extended indication from adults to pediatric patients 5-17 years* Safety and effectiveness of PEGASYS, alone or in combination with COPEGUS in patients < of 5 years have not been established* Pediatric patients treated with PEGASYS plus COPEGUS combination therapy showed a delay in weight and height increases after 48 weeks of therapy compared with baseline. At the end of 2 years follow-up after treatment, most patients returned to baseline normative growth curve percentiles for weight and height* Decreases in hemoglobin, neutrophils and platelets may require dose reduction or permanent discontinuation from treatment * If toxicities occur which may be related to PEGASYS or COPEGUS administration, the dose of one or both can be modified* Adverse reactions were similar to adults* Information on dosing, clinical trial, and adverse reactions Antiviral
07/22/2011 GAMMAGARD LIQUID Immune Globulin Infusion (Human)* Treatment of patients with primary immunodeficiency associated with defects in humoral immunity in adults and pediatric patients two years of age or older See Package Insert for new information on biologics Immunomodulator
07/19/2011 CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant* Postmarketing Study See Package Insert for new information on biologics Preventive Vaccine
07/15/2011 Topamax topiramate Monotherapy for partial onset or primary generalized tonic-clonic seizures * Expanded age range down to 2 years; previously approved for monotherapy for partial onset or primary generalized tonic-clonic seizures in patients10 years and older * Information on weight based dosing in 2 to < 10 years* Postmarketing study Anticonvulsant
06/15/2011 Zenpep pancrelipase Postmarketing study * New dosage strength of 3,000 USP lipase units to allow for dosing in infants less than 12 months* Postmarketing study Pancreatic enzyme
06/10/2011 Creon pancrelipase Postmarketing study * New dosage strength of 3,000 USP lipase units to allow for dosing in infants less than 12 months* Postmarketing study Pancreatic enzyme
06/01/2011 KEDBUMIN Albumin (Human)* Hypovolemic shock, Hypoalbuminemia, Prevention of central volume depletion after paracentesis due to cirrhotic ascites, Ovarian Hyperstimulation Syndrome (OHSS), Adult Respiratory Distress Syndrome (ARDS), Burns, Hemodialysis patients undergoing long term dialysis, Patients who cannot tolerate substantial volumes of salt solution, Priming solution for cardiopulmonary bypass See Package Insert for new information on biologics albumin
05/17/2011 Faslodex Injection fulvestrant Use in girls with progressive precocious puberty associated with McCune-Albright Syndrome * Efficacy has not been demonstrated in girls with McCune-Albright Syndrome associated with progressive precocious puberty* Information on dosing, adverse reactions, pharmacokinetics and clinical trial Estrogen lowering agent
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

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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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