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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 583
n = 533 with New Pediatric Studies; n = 50 with No New Pediatric Studies
BPCA only = 165; BPCA + PREA = 80; PREA only = 288; Rule = 49; None = 1

Pediatric Labeling Changes as of June 30, 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:  583
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
06/26/2015 Kaletra lopinavir/ ritonavir Postmarketing study * Kaletra should not be administered once daily in pediatric patients * A multicenter, randomized, open-label study evaluated the efficacy and safety of twice-daily versus once-daily dosing of Kaletra tablets dosed by weight as part of combination antiretroviral therapy in 173 HIV-1 infected children less than 18 years weighing 15 kg or more. At week 24, efficacy was significantly higher in pediatric patients receiving twice daily dosing compared to those receiving once daily dosing * The safety profile was similar between the two treatment arms although there was a greater incidence of diarrhea in the once daily treated subjects * Information on clinical trial * Postmarketing study Anticonvulsant
06/19/2015 Fycompa perampanel Treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older * Safety and efficacy in pediatric patients 12 years and older was established in a randomized double-blind, placebo-controlled, multicenter trial, which included 11 pediatric patients 12 to 16 years exposed to Fycompa; an additional 6 patients were treated with Fycompa in the open label extension of the study * Safety and effectiveness in pediatric patients less than 12 years of age have not been established * Adverse reactions were similar to those observed in adults * Information on dosing, PK, clinical studies, and adverse reactions * New indication Anticonvulsant
06/12/2015 Zomig Nasal Spray zolmitriptan Acute treatment of migraine with or without aura in adolescents 12 to 17 years old * Efficacy in pediatric patients 12 to 17 years was established in a placebo-controlled study with 81 pediatric patients receiving Zomig 2.5 mg and 229 pediatric patients receiving Zomig 5 mg * Safety of Zomig nasal spray in the acute treatment of migraine in pediatric patients 12 to 17 years of age was established i n two studies * Safety and effectiveness of in pediatric patients under 12 years have not been established * Adverse reactions were similar to those observed in adults * Information on dosing, clinical trials, adverse reactions * Postmarketing study Antimigraine
05/27/2015 Asacol mesalamine Maintenance of remission of mildly to moderately active ulcerative colitis *Safety and effectiveness for the maintenance of remission of mildly to moderately active ulcerative colitis in pediatric patients have not been established *Efficacy was not demonstrated in a randomized, double-blind 26-week trial of two dosage levels in 39 patients aged 5 to 17 years Anti-inflammatory
05/18/2015 Lamictal lamotrigine Maintenance treatment of bipolar disorder * Safety and efficacy for the maintenance treatment of bipolar disorder were not established in a double-blind, placebo-controlled trial that evaluated 301 pediatric patients aged 10 to 17 *Information on clinical trial and adverse reactions *Postmarketing study Anticonvulsant; Mood Stablizer
05/14/2015 Treximet sumatriptan/naproxen Acute treatment of migraine with or without aura * Safety and efficacy for the acute treatment of migraine in pediatric patients 12 to 17 years of age were established in a double-blind, placebo-controlled trial *Safety and effectiveness in pediatric patients under 12 years of age have not been established *The safety of treating an average of more than 2 migraine headaches in pediatric patients in a 30-day period has not been established *Information on dosing, adverse reactions, pharmacokinetics clinical studies *Postmarketing study Antimigraine
05/14/2015 IXINITY Coagulation Factor IX (Recombinant)* Indicated in adults and children equal to or greater than 12 years of age with hemophilia B for control and prevention of bleeding episodes, and for perioperative management See Package Insert for new information on biologics Antihemophilic Factor
04/27/2015 Tarceva erlotinib Recurrent or refractory ependymoma *Safety and effectiveness in pediatric patients have not been established. * In an open-label, multi-center trial, 25 pediatric patients (median age 14 years, range 3-20 years) with recurrent or refractory ependymoma were randomized to Tarceva or etoposide. * Safety and effectiveness in pediatric patients have not been established. * In an open-label, multi-center trial, 25 pediatric patients (median age 14 years, range 3-20 years) with recurrent or refractory ependymoma were randomized to Tarceva or etoposide. * The trial was terminated prematurely for lack of efficacy. * No new adverse events were identified in the pediatric population. * Information on clinical trial and population pharmacokinetics Antineoplastic
04/23/2015 Valcyte valganciclovir Prevention of cytomegalovirus disease in heart transplant patients *Extended indication down to 1 to 4 months; previously approved in 4 months and older. *Extended the duration of dosing regimen from 100 days to 200 days post-transplantation for the prevention of CMV disease in pediatric kidney transplant patients 4 months to 16 years. *Safety and efficacy have not been established in children for prevention of CMV disease in pediatric liver transplant patients, in kidney transplant patients less than 4 months of age, in heart transplant patients less than 1 month of age, in pediatric AIDS patients with CMV retinitis, and in infants with congenital CMV infection. *Monitor serum creatinine levels regularly and consider changes in height and body weight and adapt the dose as appropriate during prophylaxis period. *Higher incidence of neutropenia in the two pediatric studies as compared to adults, but there was no correlation between neutropenia and infections observed in the pediatric population. *The overall safety profile was similar with the extension of prophylaxis until Day 200 posttransplant in high risk pediatric kidney transplant patients. However, the incidence of severe neutropenia was higher in pediatric kidney transplant patients treated with VALCYTE until Day 200 (17/57, 30%) compared to pediatric kidney transplant patients treated until Day 100 (3/63, 5%). *Information on dosing, pharmacokinetics, clinical studies Antiviral
04/17/2015 Aptensio XR methylphenidate hydrochloride Attention Deficit Hyperactivity Disorder *Safety and effectiveness of have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled clinical trials. * Safety and effectiveness in pediatric patients under six years have not been evaluated. *The long-term efficacy of methylphenidate in pediatric patients has not been established. * CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor weight and height in pediatric patients treated with CNS stimulants, including Aptensio XR. Pediatric patients not growing or gaining weight as expected may need to have their treatment interrupted. * Information on dosing, adverse reactions, and clinical trials CNS Stimulant
03/31/2015 ProAir RespiClick albuterol sulfate Treatment or prevention of bronchospasm and prevention of exercise induced bronchospasm *Safety and effectiveness for the treatment or prevention of bronchospasm in children 12 - 17 years and older with reversible obstructive airway disease is based on two12-week clinical trials, one long-term safety study and one -single-dose cross over study *The safety and effectiveness for treatment of exercise-induced bronchospasm in children 12 years of age and older is based on one single dose crossover study *The safety profile for patients 12 to 17 years was consistent with the overall safety profile seen in adults *The safety and effectiveness in pediatric patients below the age of 12 years have not been established. 120 children with asthma ages 4 to 11 years participated in the clinical program *Information on clinical trials, and adverse reaction information in adults and children 12 years and older *New dosage form Antiasthma
03/27/2015 Eovist gadoxetate disodium Postmarketing study *An adequate and well-controlled study was not conducted. An observational study was performed in 52 patients 2 months and less than18 years with suspected or known focal liver lesions. Eovist improved border delineation and increased contrast of the lesion in the majority of patients when compared to non-contrast images. *Safety and effectiveness have not been established in premature infants *No new safety issues were identified *No case of nephrogenic systemic fibrosis associated with Eovist or any other Gadolinium-based contrast agent has been identified in pediatric patients ages 6 years and younger *Postmarketing study Medical Imaging
03/26/2015 Oraltag iohexol Computed tomography of the abdomen and pelvis *Safety and effectiveness of oral iohexol have been established in pediatric patients *Information on dosing and preparation and administration instructions *New dosage form Medical Imaging
03/24/2015 Quadracel Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine Indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis See Package Insert for new information on biologics Preventative vaccine
03/23/2015 Epivir lamivudine HIV * Labeling revised to provide for once-daily dosing in pediatric patients 3 months of age *Information on clinical trial *New dosing Antiviral
03/23/2015 Ziagen abacavir HIV * Labeling revised to provide for once-daily dosing in pediatric patients 3 months of age *Information on clinical trial *Postmarketing study Antiviral
03/18/2015 Intuniv guanfacine Long-term maintenance treatment of ADHD *Information added to labeling regarding a long-term, placebo-controlled monotherapy maintenance trial in 6-17 years *Increases in mean systolic and diastolic blood pressure, of approximately 3 mmHg and 1 mmHg respectively, above original baseline were observed upon discontinuation of Intuniv *Information on adverse reactions and clinical trial *Postmarketing study Non-stimulant ADHD treatment
03/12/2015 Saphris asenapine Treatment of Schizophrenia and Acute Manic or Mixed Episodes Associated with Bipolar I Disorder *Bipolar I Disorder *Safety and efficacy were established in a 3-week, placebo-controlled, double-blind trial of 403 pediatric patients ages 10 to 17 years, at fixed doses ranging from 2.5 mg – 10 mg twice daily *Safety and efficacy in patients less than 10 years of age have not been evaluated *In a Phase 1 study, pediatric patients aged 10 to 17 years appeared to be more sensitive to dystonia when the recommended dose escalation schedule for initial dosing was not followed *Adverse reactions: somnolence, dizziness, dysgeusia, oral paresthesia, nausea, increased appetite, fatigue, increased weight. Fatigue dose related *Monitor weight compared to expectations for normal growth. Weight gain (greater than or equal to 7%. increase in body weight) higher than placebo , Saphris 2.5 mg twice daily, 5 mg twice daily and 10 mg twice daily (1.1%, 12%, 8.9% and 8 % respectively) *No additional new major safety findings were reported from a 50-week, open-label, uncontrolled safety *Safety and efficacy for adjunctive therapy in the treatment of bipolar I disorder have not been established in the pediatric population. *Schizophrenia *Efficacy was not demonstrated in an 8-week, placebo-controlled, double-blind trial, in 306 adolescent patients aged 12 to17 years with schizophrenia *Safety and efficacy in patients less than 12 years have not been evaluated, *The most common adverse reactions reported were somnolence, akathisia, dizziness, and oral hypoesthesia or paresthesia. * Monitor weight gain compared with tht expected for normal growth. Increases in body weight of at least 7% increase in body weight at endpoint compared to baseline for placebo, Saphris 2.5 mg twice daily, and Saphris 5 mg twice daily was 3%, 10%, and 10%, respectively *Adverse reactions identified in the pediatric schizophrenia trial were generally similar to those observed in the pediatric bipolar and adult bipolar and schizophrenia trials *No new major safety findings were reported from a 26-week, open-label safety trial in pediatric patients with schizophrenia treated with Saphris monotherapy *Information on dosing, adverse reactions, lab abnormalities, and clinical trials *Postmarketing study Antipsychotic
03/12/2015 Xopenex HFA Inhalation levalbuterol Asthma or reactive airway disease *Not indicated for pediatric patients less than 4 years of age. A 4 week randomized, placebo-controlled clinical trial in pediatric patients below the age of 4 years showed no statistical significant difference between treatment groups in the primary efficacy endpoint *There was an increased incidence of asthma-related adverse reactions reported in Xopenex HFA-treated pediatric patients compared to placebo in this age group *Information on clinical trial *Postmarketing study Antiasthmatic
02/26/2015 Liletta levonorgestrel-releasing intrauterine system Prevention of pregnancy for up to 3 years *Safety and efficacy have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal females under 16 years and for users 16 years and older *Use before menarche is not indicated *New drug Contraceptive
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: * Seasonal allergic rhinitis in patients aged 2 though 6 years, including dosing information *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
02/20/2015 Dymista azelastine hydrochloride and fluticasone proprionate Treatment of symptoms of seasonal allergic rhinitis *Approved for use in pediatric patients 6 to 11 years based on safety and efficacy data from clinical studies of 416 patients and the established efficacy and safety of azelastine hydrochloride nasal spray and fluticasone propionate nasal spray in this age group; previously approved in 12 years and older *Safety findings in children 4-5 years of age were similar to those in children 6-11 years, but efficacy was not established *Safety and effectiveness of have not been studied in pediatric patients below the age of 4 years *Information on clinical trial and adverse reactions *Postmarketing study Antiallergy
02/12/2015 Banzel rufinamide Adjunctive treatment of seizures associated with Lennox Gastaut Syndrome *Safety and effectiveness have been established in pediatric patients down to 1 year; Previously approved in 4 years and older. *The effectiveness in patients in patients 1 to less than 4 years was based upon a bridging pharmacokinetic and safety study *Safety and effectiveness in pediatric patients below the age of 1 year has not been established *Adverse reactions were similar to those observed in adults and pediatric patients 4 years and older *Information on clinical trial, dosing and adverse reactions in 1 to less than 4 years Anticonvulsant
02/06/2015 Dutrebis lamivudine and raltegravir Treatment of HIV-1 infection *Indicated in adults and pediatric patients 6 - 16 years and weighing at least 30 kg *Should not be used in children below 6 years or in patients weighing less than 30 kg due to weight based dosing requirements in this patient population *Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue treatment as clinically appropriate *The PK of Dutrebis in the pediatric population has not been studied in clinical trials. Based on modeling and simulation using raltegravir PK data in adults, the PK of raltegravir in Dutrebis in children was projected to result in exposures that have been previously shown to be safe and efficacious in adults *Information on dosing *New drug Antiviral
01/30/2015 Pazeo olopatadine hydrochloride Ocular itching associated with allergic conjunctivitis *Safety and effectiveness have been established in pediatric patients 2 years and older. Use in these pediatric patients is supported by evidence from adequate and well-controlled studies in adults and an adequate and well controlled study evaluating the safety in pediatric and adult patients *New formulation Antihistamine, topical
01/23/2015 BEXSERO Meningococcal Group B Vaccine* Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in patients 10 through 25 years of age See Package Insert for new information on biologics Preventative Vaccine
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 Antiasthma
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 Antiinflammatory, 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. nd the following Aprecancerous 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 Preventative 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
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 established 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 Partial onset seizures (POS, 1 mo to 16 years), Primary generalized tonic clonic seizures (PGTC, 6- 16 years), 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 noeurocognitive 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

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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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