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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
02/20/2015 Astepro Nasal Spray azelastine Seasonal allergic rhinitis; Perennial allergic rhinitis • One 4-week open-label study of 191 pediatric patients from 6 months to 5 years established safety and reduced allergic rhinitis sympsoms. These data supported treatment of: o Seasonal allergic rhinitis in patients aged 2 though 6 years, including dosing informatio • Perennial allergich rhinitis in pediatric patients aged 6 months through 6 years, including dosing information. The safety and effectiveness of ASTEPRO in patients below 6 months of age have not been established Antiallergy
01/22/2015 Xopenex Inhalation Solution levalbuterol Asthma or reactive airway disease • Efficacy was not established in one adequate and well controlled trial in 291 pediatric patients from 2 to 5 years, and another adequate and well controlled trial of 88 pediatirc patients from birth to less than 2 years. • Adverse reactions in both studes were consistent with adverse reactions in patients 6 years and older. • Increased number of asthma-related adverse reactions following chronic XOPENEX treatment compared to control. • XOPENEX Inhalation Solution is not indicated for pediatric patients less than 6 years of age Antiasthmatic
01/16/2015 Cutivate fluticasone propionate Atopic dermatitis • Extended the use of Cutivate from patients aged 1 year and older down to 3 months and older • Reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression in 1 patient under 1 year • The safety and effectiveness of Cutivate Lotion in pediatric patients below 3 months of age have not been established Anti-inflammatory, topical
12/30/2014 Natroba spinosad Head lice infestation • Extended the use of Natroba to pateints aged 6 months and older. • A 23-day open-label study assessed the pharmacokinetic profile of spinosad 0.9% and the ingredient benzyl alcohol in pediatric patients in 26 pediatric patients aged between 6 months to 4 years • Plasma spinosad and benzyl alcohol concentrations at 12 hours post-treatment were below limit of quantification for all subjects tested • Safety in pediatric patients below the age of 6 months has not been established Pediculocide, topical
12/29/2014 Gadavist gadobutrol Detection and visualization of areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system • Extended the indication to pediatric patients from bith at age 37 weeks gestation up to 2 years of age, based on two adequate and well controlled studies in 44 ages 0 to less than 2 years and extrapolation from of adult CNS efficacy data • The frequency, type, and severity of adverse reactions in pediatric patients were similar to those in adults • Dosing established [0.1 mL/kg body weight (0.1 mmol/kg)] • PK studies suggest that clearance of Gadavist is similar in pediatric patients and adults, including pediatric patients age younger than 2 years • Juvenile toxicity studies in rats did not reveal findings suggestive of a specific risk for use in pediatric patients including term neonates and infants Medical imaging
12/23/2014 Taclonex calcipotriene/ betamethasone dipropionate Psoriasis vulgaris • Extended the indication for psoriasis down to pediatric patients 12 to 17 years , based on adequate and well controlled studies in adults supported by a 4 week safety study in 33 patients 12 years and older • Patients with plaque psoriasis involving 5-30% of the body surface area were treated with Taclonex Ointment for 4 weeks up to a maximum of 55.8 g per week • Maximum weekly dose established (60 g per week) Vitamin D analog
12/19/2014 Merrem I.V. meropenem Complicated intra-abdominal infections • Indication extended to pediatric patients less than 3 months of age with intra-abdominal infections • Efficacy for cIAI upported by evidence from adequate and well-controlled studies in adults with additional data from a pediatric PK and safety study • A PK study was conducted in pediatric patients less than 3 months of age, including preterm infants • Dosing for patients with normal renal function in this age group is based on gestational age and postnatal age Antibiotic
12/17/2014 QNASL beclomethasone dipropionate Treatment of the nasal symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis • Indication extended to pediatric patients aged 4 years and older • The efficacy and safety of QNASL Nasal Aerosol have been established in 2 clinical trials of 2 to 12 weeks duration in total of 1255 pediatric patients 4 to 11 years of age with symptoms of seasonal or perennial allergic rhinitis • The local nasal effects in children aged 4-11 years were similar to those reported in patients 12 years of age and older in clinical trials • Dosing information for children aged 4-11 years • The safety and effectiveness of QNASL Nasal Aerosol in children younger than 4 years of age have not been established Antiallergy
12/17/2014 Xtoro finafloxacin Treatment of acute otitis externa • New approval • The safety and efficacy of XTORO in treating acute otitis externa in pediatric patients one year or older have been demonstrated in two randomized multicenter, vehicle controlled clinical trials in total of 1234 patients aged 6 months to 85 years • PK analyses were performed in 14 healthy adult volunteers and 36 patients ages 6 years and older with AOE • The safety and efficacy of XTORO below one year of age have not been established Anti-inflammatory, topical
12/10/2014 Gardasil 9 Human Papillomavirus 9-valent Vaccine, Recombinant* Indicated in girls and women 9 through 26 years of age for prevention of the following diseases: •Cervical, vulvar, vaginal, and anal cancer caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58. •Genital warts (condyloma acuminata) caused by HPV types 6 and 11 and the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58: •Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS). •Cervical intraepithelial neoplasia (CIN) grade 1. •Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3. •Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3. Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. Human Papillomavirus 9-valent Vaccine, Recombinant is indicated in boys 9 through 15 years of age for the prevention of the following diseases: •Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58. •Genital warts (condyloma acuminata) caused by HPV types 6 and 11. And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58: •Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 See Package Insert for new information on biologics Preventive vaccine
11/25/2014 Priftin rifapentine Treatment of latent tuberculosis infection (LTBI) caused by Mycobacterium tuberculosis in combination with isoniazid (INH) • At the time of approval, the safety and effectiveness of PRIFTIN in combination with isoniazid (INH) once-weekly regimen for the treatment of LTBI was established • A study of 742 pediatric patients (2-17 years of age) compared the effectiveness of 12 weekly doses of PRIFTIN in combination with INH (3RPT/INH arm) administered by directly observed therapy to 9 months of self-administered daily INH (9INH arm) • The safety profile in children in clinical studies was similar to that observed in adults • Weight based dosage recommendations for treatment of LTBI Antibiotic
11/20/2014 Kapvay Extended Release Tablets clonidine Attention Deficit Hyperactivity Disorder (ADHD) • One additional study was conducted • A 40-week, dose optimization, randomized withdrawal study of 135 pediatric patients 6 to 17 years • Blood pressure (BP): Mean increases in both systolic and diastolic BP (SBP/DBP) Hg were seen in drug treated patients • Heart rate (HR): Mean decreases in HR were noted in drug treated patients Non-stimulant ADHD treatment
11/19/2014 Intuniv guanfacine Attention Deficit Hyperactivity Disorder (ADHD) • Two new pediatric studies were conducted • A 15-week study conducted in 314 adolescents aged 13-17 years • A 12-week (for children aged 6-12) or 15-week (for adolescents aged 13-17) study conducted in 337 pediatric patients aged 6-17 years inclusive • New dosing regimen (weight-based dosing up to 7 mg/day in adolescents) • Effectiveness for longer than 15 weeks has not been evaluated in controlled trials in pediatrics • Safety and efficacy in pediatric patients less than 6 years have not been establishd Non-stimulant ADHD treatment
10/31/2014 Lexapro escitalopram oxalate Major depressive disorder • An open-label safety study in 118 children aged 7-11 years who had MDD, did not identify any new safety concerns. Efficacy was not established in this study Antidepressant
10/30/2014 Keppra levetiracetam Partial onset seizures in patients 1 month and older; Primary generalized tonic-clonic seizures in patients 6 years and older; Myoclonic seizures in patients with juvenile myoclonic epilepsy 12 years and older • Safety and efficacy established for adjunctive treatment of o Partial onset seizures (POS, 1 mo to 16 years) o Primary generalized tonic clonic seizures (PGTC, 6- 16 years) o Myoclonic seizures (12-16 years) • Efficacy for adjunctive treatment of POS established in two multicenter, randomized double-blind, placebo-controlled trials: one trial enrolled 198 patients aged 4-16 years; the other enrolled 116 patients aged 1 month to less than 4 years with partial seizures, uncontrolled by standard epileptic drugs • Efficacy for adjunctive treatment of PGTC established in one multicenter, randomized double-blind, placebo-controlled trial in 164 patients aged 6 years and older with idiopathic generalized epilepsy experiencing primary generalized tonic-clonic seizures • Efficacy for adjunctive treatment of myoclonic seizures established in one multicenter, randomized double-blind, placebo-controlled trial in 120 patients aged 12 years and older with juvenile myoclonic epilepsy experiencing myoclonic seizures • PK studies in pediatric patients established weight-based dosing • In a 3-month, randomized, double-blind, placebo-controlled study of levetiracetim in 98 patients, aged 4-16 years with partial seizures that were inadequately controlled on prior therapy, there were no eurocognitive or behavioral differences between levetiracetim and placebo • Common adverse reactions in pediatric patients include fatigue, aggression, nasal congestion, decreased appetite, irritability, decrease in WBC and neutrophil counts, increase in diastolic blood pressure • Age-specific toxicity was studied in juvenile rates and dogs at doses of up to 1800 mg/kg/day and did not indicate a potential for age-specific toxicity Anticonvulsant
10/29/2014 Trumenba Meningococcal Group B Vaccine* Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B See Package Insert for new information on biologics Vaccine
10/23/2014 Zetonna ciclesonide Postmarketing study • Efficacy and safety were established in pediatric patients aged 6-11 years with perennial allergic rhinitis in one 12 week, randomized, double blind, parallel placebo-controlled, 2 dose clinical trial with 846 pediatric patients • Long-term nasal and ocular safety were evaluated in one 26-week, postmarketing, randomized, open-label, active-controlled trial in a total of 737 patients 12-74 years of age. Epistaxis was observed in 6% of patients • Efficacy was not established in pediatric patients aged 6-11 years with seasonal allergic rhinitis in one 2 week, randomized, double blind, parallel placebo-controlled, 2 dose clinical trial (n= 847) • The effect on the HPA axis was evaluated in one 6 week study in children aged 6-11 years with perennial allergic rhinitis and results were consistent with the fundings observed in the adolescents • The safety in 6 to 11 year old children was similar to patients 12 years and older and no new safety concerns were identified • Studies in children under 6 years of age have not been conducted Antiasthmatic; antiallergy
10/16/2014 Cymbalta duloxetine hydrochloride Generalized Anxiety Disorder • The safety and efficacy for GAD in 7 to 17 years of age was demonstrated in one 10-week, placebo-controlled trial (n=272) • Safety and effectiveness in pediatric patients less than 7 years have not been established • The most frequently observed ARs in the pediatric trials included nausea, headache, weight reduction, and abdominal pain • Weight and height should be regularly monitored in children and adolescents treated with duloxetine • The average steady-state duloxetine concentration was about 30% lower in children and adolescents relative to adults Antidepressant
10/10/2014 Naftin naftifine hydrochloride Interdigital tinea pedis * Use in 12 – 18 years is supported by evidence from adequate and well controlled studies in adults with additional safety and PK data from an open label trial in 22 adolescents 12 years and older exposed to Naftin Gel at a dose of approximately 4 g/day * Safety and effectiveness in pediatric patients less than12 years have not been established * Adverse reactions were similar to those observed in adults * Postmarketing study Antifungal, topical
09/12/2014 RIXUBIS Coagulation Factor IX (Recombinant)* Control and prevention of bleeding episodes, perioperative management, and routine prophylaxis See Package Insert for new information on biologics Coagulant
09/10/2014 Emsam selegiline Treatment of major depressive disorder * Multi-center, randomized, double-blind, placebo-controlled, flexible-dose trial in 308 adolescents 12 – 17 years failed to demonstrate efficacy * Emsam should not be used in patients less than 18 years. * Use in patients less than 12 years is contraindicated because of the potential for a hypertensive crisis, which may be increased compared to adolescents and adults based on limited PK data suggesting higher exposure even at the lowest dose * Adverse events were similar to those observed in adults * Postmarketing study Antidepressant
09/04/2014 Latisse bimatoprost Treatment of hypotrichosis * Use was evaluated in a 16 week double-masked, randomized, vehicle controlled study in pediatric patients with several different conditions (post-chemotherapy, alopecia areata, and adolescents with hypotrichosis and no associated medical condition *No new safety issues were observed * Postmarketing study Antiglaucome
08/29/2014 Taclonex calcipotriene/ betamethasone dipropionate Plaque psoriasis of the scalp *Expanded the indication from adults to pediatric patients 12 – 17 years * Safety and effectiveness have not been established in pediatric patients less than 12 years * In a trial to evaluate the effect on HPA axis suppression in pediatric patients 12 – 17 years, adrenal suppression was identified in 1 of 30 patients (3.3%) after 4 weeks of treatment * Rare systemic toxicities such as Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids *Local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients * Information on dose and maximum weekly dose, adverse reactions, and clinical trials * Postmarketing study Anti-inflammatory, topical
08/20/2014 Arnuity Ellipta fluticasone furoate Maintenance treatment of asthma as prophylactic therapy * Approved for use in adults and pediatric patients 12 years and older * Safety and efficacy in pediatric patients younger than 12 years have not been established * Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to children and adolescents. The growth of children and adolescents receiving orally inhaled corticosteroids, including Arnuity Ellipta, should be monitored routinely. The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks associated with alternative therapies * Information on safety, adverse events and clinical trials * New dosage form Antiasthmatic
08/01/2014 Keppra XR levetiracetam Adjunctive therapy in the treatment of partial onset seizures * Safety and effectiveness in pediatric patients 12 years and older have been established based on PK data in adults and adolescents using Keppra XR and efficacy and safety data in pediatric studies using immediate-release Keppra * Safety and effectiveness of in patients below the age of 12 years have not been established * Information on PK parameters and PK study *Postmarketing study Anticonvulsant
07/03/2014 Namenda XR memantine hydrochloride Autism spectrum disorders *The safety and effectiveness of memantine have not been established in pediatric patients *Memantine failed to demonstrate efficacy in two 12-week controlled clinical studies of 578 pediatric patients aged 6-12 years with autism spectrum disorders *Adverse reactions were similar to those observed in adults* Information on dosing, adverse reactions, clinical trials
06/09/2014 Abilify aripiprazole Maintenance treatment of irritability associated with autistic disorder *Efficacy for the maintenance treatment of irritability associated with autistic disorder was not established in a 12 week clinical trial in 85 pediatric patients 6-17 years * Information on clinical trial* Postmarketing study Antipsychotic
06/02/2014 Reyataz atazanavir Treatment of HIV - 1 infection *Reyataz oral powder approved for use in pediatric patients at least 3 months and between 10 kg to less than 25 kg; capsule previously approved in 6 years and older* Not recommended in pediatric patients less than 3 months because of the risk of kernicterus* Reyataz oral powder contains phenylalanine which can be harmful to patients with phenylketonuria * Adverse reactions were similar to those observed in adults* Oral powder must be mixed with food or beverage for administration and ritonavir must be given immediately afterwards * Information on mixing oral powder with food such as appleasauce or yogurt or milk, water or infant formula * Information on dosing in patients at least 3 months and weighing between 10 to less than 25kg, adverse reactions, laboratory abnormalities, PK parameters, and clinical trials* New dosage form Antiviral
05/27/2014 Aloxi palonosetron hydrochloride Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) and postoperative nausea and vomiting (PONV) Chemotherapy-Induced Nausea and Vomiting *Approved for prevention of acute CINV in 1 month - < 17 years* Safety and effectiveness in neonates less than 1 month of age have not been established* Pediatric patients require a higher palonosetron dose than adults (20 mcg/kg with max of 1.5 mg x 1 vs 0.25 mg x 1 *Adverse reactions were similar to those observed in adults *Information on dosing, PK parameters, clinical trial, adverse reactions Postoperative Nausea and Vomiting Studies *Safety and efficacy have not been established in pediatric patients for PONV *Adverse reactions were similar to those observed in adults* Information on dosing, clinical trials Antiemetic
04/28/2014 Delzicol mesalamine Treatment of mildly to-moderately active ulcerative colitis *Approved for use in pediatric patients 12 years and older based on clinical trials conducted with mesalamine 400 mg delayed release tablets which is approved in 5-17 years* Delzicol is bioequivalent to the mesalamine delayed-release tablets *There is no age appropriate Delzicol formulation available for patients less than 12 years *Safety and effectiveness of Delzicol in the maintenance of remission of ulcerative colitis in pediatric patients have not been established *Information on dosing* New dosage form Anti-Inflammatory
04/25/2014 Asmanex HFA mometasone furoate Maintenance treatment of asthma as prophylactic therapy *Approved for use in adults and pediatric patients 12 years and older *Safety and efficacy hav not been established in children less than 12 years *The growth of pediatric patients receiving orally inhaled corticosteroids should be monitored routinely *To minimize the systemic effects of orally inhaled corticosteroids each patient should be titrated to his/her lowest effective dose *Information on dosing, adverse reactions, and clinical trials *New dosage form Antiasthmatic
04/23/2014 Kuvan sapropterin dihydrochloride Treatment to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU) * Expanded indication to include 1 month to 4 years; previously approved for use in 4 years and older * Safety and effectiveness have not been established in neonates * Adversereactions observed in pediatric patients 1 month – 6 years were similar to adults except for an increased incidence of low Phe levels. 25% (16/65) experienced low Phe for age * Information on adding crushed tablet or powder for oral solution to small amounts of soft food such as apple sauce* Information on dosing, adverse reactions, PK parameters, and clinical trials
04/11/2014 GRASTEK Timothy Grass Pollen Allergen Extract* Treatment of grass pollen-induced allergic rhinitis or conjunctivitis See Package Insert for new information on biologics Immunologic agent
04/01/2014 ORALAIR Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract* Treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis See Package Insert for new information on biologics Antiallergy
03/28/2014 Topamax topiramate Prophylaxis of migraine headache * Approved for use in pediatric patients 12 years and older * Safety and effectiveness in pediatric patients less than12 years have not been established for the prophylaxis treatment of migraine headache * In the adolescent migraine trials (12 to 17 years), the most commonly observed adverse reactions were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain * The most common cognitive adverse reaction in pooled double-blind studies in adolescent patients 12 to 17 years was difficulty with concentration/attention * Markedly abnormally low serum bicarbonate values indicative of metabolic acidosis were reported in topiramate-treated adolescent migraine patients * In topiramate-treated patients 12 to 17 years compared to placebo-treated patients, abnormally increased results were more frequent for creatinine, BUN, uric acid, chloride, ammonia, total protein, and platelets. Abnormally decreased results were observed with topiramate vs placebo treatment for phosphorus and bicarbonate * Notable changes (increases and decreases) from baseline in systolic blood pressure, diastolic blood pressure, and pulse were observed more commonly in adolescents treated with topiramate compared to adolescents treated with placebo * Information on dosing, adverse reactions, laboratory abnormalities, and clinical trials * Postmarketing study Antimigraine
03/21/2014 Xolair omalizumab Chronic Idiopathic Urticaria (CIU) * Approved for the treatment of CIU in adults and pediatric patients 12 years and older who remain symptomatic despite H1 antihistamine treatment * Clinical studies with Xolair have not been conducted in CIU patients less than 12 years. Considering the risk of anaphylaxis and malignancy seen in Xolair-treated patients 12 years and older, the use of Xolair in patients less than 12 years is not recommended * Dosing in CIU is not based on serum IgE level or body weight * Adverse reactions in adolescents and adults were similar and include miscellaneous infections, arthralgias, headache, nausea, and cough * Information on adverse reactions, dosing, and clinical trials in adults and pediatric patients 12 years and older Antiasthmatic; antiallergy
03/20/2014 Baraclude entecavir Treatment of chronic hepatitis B virus (HBV) infection * Approved for use in pediatric patients 2 years and older * Safety and effectiveness have not been established in pediatric patients less than 2 years. Use in this age group has not been evaluated because treatment of HBV in this age group is rarely required * There are limited data available on the use of Baraclude in lamivudine-experienced pediatric patients * Adverse reactions in clinical trials were similar to those observed in adults * Information on dosing in pediatric patients 2 years and weighing at least 10 kg, adverse reactions, PK parameters and clinical trials * New dosage form Antiviral
03/07/2014 Pancreaze pancrelipase Postmarketing study *New dosage strength of 2,600 USP lipase units to allow for dosing in infants up to 12 months*Postmarketing study* New dosage form Pancreatic enzyme
03/06/2014 Revatio sildenafil Treatment of pulmonary arterial hypertension (PAH) *Labeling updated to include information on results of an open-label pediatric safety extension study* During the study, there were 42 deaths with 37 of these deaths reported prior to a decision to titrate patients to a lower dosage because of a finding of increased mortality. An increase in mortality was observed with increasing doses *Causes of death in the extension study were typical of patients with PAH Peripheral vasodilator
01/22/2014 Xerese acyclovir/ hydrocortisone Treatment of recurrent herpes labialis * Expanded indication to include 6 years to less than 12 years; previously approved for use in 12 years and older *Safety and effectiveness in pediatric patients less than 6 years of age have not been established *Adverse reactions similar to those observed in adults* Information on dose, and clinical trial Antiviral, topical
01/17/2014 Aleve PM naproxen sodium 220 mg and diphenhydramine hydrochloride 25 mg Relief of occasional sleeplessness when associated with minor aches and pains and helps fall asleep and stay asleep *Approved for use in adults and children 12 years and older * Not approved for use in children less than 12 years* New drug anti-inflammatory+sleep aid
12/20/2013 Isentress raltegravir HIV-1 infection *Packet for oral suspension: Approved for use in infants 4 weeks and older, weighing at least 3 kg to < 20 kg. Chewable tablet previously approved down to 2 years* Safety and dosing information have not been established in infants less than 4 weeks *Adverse reactions similar to those observed in adults* Information on dosing,clinical trial and PK parameters*Information on preparation of a suspension*New dosage form Antiviral
12/10/2013 Xeloda capecitabine Newly diagnosed brainstem gliomas and high grade gliomas *The safety and effectiveness in pediatric patients have not been established *No clinical benefit was demonstrated in 2 single arm trials in pediatric patients* The adverse reaction (AR) profile was consistent with the known AR profile in adults, with the exception of laboratory abnormalities which occurred more commonly in pediatric patients* Information on dosing, adverse reactions, and clinical trials Antineoplastic
11/25/2013 Noxafil posaconazole Prophylaxis of invasive Aspergillus and Candida infections in high risk patients *Safety and effectiveness have been established in pediatric patients 13 - 17 years. Use is supported by evidence from adequate and well-controlled studies in adults. PK and safety in pediatric patients 13 - 17 years were also assessed and are similar to adults.* Safety and effectiveness in pediatric patients less than 13 years have not been established* Information on dosing, PK, and clinical trials Antifungal
11/22/2013 Nitropress sodium nitroprusside Immediate reduction of blood pressure in hypertensive crisis *Efficacy in the pediatric population was established based on adult trials and supported by a dose-ranging trial and an open label trial that achieved adequate mean arterial pressure control in pediatric patients *No novel safety issues were found in these two studies. *Information on dosing, PK parameters and clinical trials Antihypertensive
10/26/2013 Sabril vigabatrin Refractory complex partial seizures (rCPS) *Approved as adjunctive therapy for pediatric patients 10 years and older with rCPS for whom the potential benefits outweigh the risk of vision loss. Sabril is not a first line agent for rCPS * Safety and effectiveness for pediatric patients less than 10 years with refractory rCPS have not been established *Pooled data from 3 controlled trials in pediatric patients demonstrated that 6% (10/165) of Sabril patients experienced somnolence compared to 5% (5/104) of placebo patients. In those same studies, 10% (17/165) of Sabril patients experienced fatigue compared to 7% (7/104) of placebo patients; 47% (77/163) of Sabril patients versus 19% (19/102) of placebo patients gained greater than or equal to 7% of baseline body weight *Adverse reactions (ARs) in the pediatric population were similar to those reported in adults. Overall, ARs in pediatric patients 10-16 years included increased weight, upper respiratory tract infection, tremor, fatigue, aggression and diplopia *Information on weight based dosing, dosing in renal impairment, safety information and clinical trials Anticonvulsant
10/24/2013 Ecoza econazole nitrate Treatment of interdigital tinea pedis *Approved for use in 12 years and older * Safety findings for patients 12 - 17 years were similar to those in adults * Information on clinical trials and PK* New dosage form Antifungal, topical
10/18/2013 Asacol HD mesalamine Postmarketing study using Asacol *Safety and effectiveness of Asacol HD in pediatric patients have not been established *Since studies were performed in Asacol rather than Asocol HD, information added to labeling referring reader to prescribing information for other approved mesalamine products for the safety and effectiveness of these products in pediatric patients Anti-inflammatory
10/18/2013 Asacol mesalamine Treatment of mildly to moderately active ulcerative colitis *Safety and effectiveness in pediatric patients 5 - 17 years have been established over a 6-week period. Use in this age group is supported by evidence from studies in adults and 1 study in pediatric patients*Safety and effectiveness in pediatric patients below 5 years have not been established*Safety and effectiveness for the maintenance of remission of ulcerative colitis in pediatric patients have not been established*Adverse reactions in the pediatric population were similar to those reported in adults*Information on dose, adverse reactions, PK and clinical trials*Postmarketing study Anti-inflammatory
10/15/2013 Novoeight Antihemophilic Factor (Recombinant)* For adults, adolescents, and children with hemophilia A for (1) the control and prevention of bleeding episodes, (2) perioperative management, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes. See Package Insert for new information on biologics

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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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