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U.S. Department of Health and Human Services

Pediatric Studies Characteristics
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This table summarizes pediatric studies that led to FDAAA pediatric labeling changes pursuant to the Best Pharmaceuticals for Children Act, and the Pediatric Research Equity Act. CBER regulated products have an asterisk (*) by the proper name. To obtain all the information for a pediatric study, 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 product, enter the trade name or generic name in the Filter box and select Show Items.

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   No. of Records Found:  397
Approval Date Trade Name Generic or Proper Name (*) Indications Studied Therapeutic Category Study Type
08/22/2011 Copegus and PEGASYS ribavirin and peginterferon alfa-2a Treatment of chronic hepatitis C in patients 5 to 17 years of age Antiviral Safety/Pharmacokinetics
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 Immunomodulator Pharmacokinetic/Tolerability
07/19/2011 CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant* Postmarketing Study Preventive Vaccine Safety/Immunogenicity
05/17/2011 Faslodex Injection fulvestrant Use in girls with progressive precocious puberty associated with McCune-Albright Syndrome Estrogen lowering agent Efficacy/Safety
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 Platelet inhibitor Pharmacokinetic/Pharmacodynamic
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 Platelet inhibitor Efficacy/Safety
04/29/2011 Kytril Injection granisetron hydrochloride Prevention of postoperative nausea and vomiting Antiemetic Efficacy/Safety
04/29/2011 Nexium IV esomeprazole Treatment of Gastroesophageal Reflux Disease (GERD) with erosive esophagitis Antiulcerative Pharmacokinetic
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) Anticonvulsant Efficacy/Safety
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) Anticonvulsant Efficacy/Safety
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 Preventive Vaccine Safety/Immunogenicity
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 Preventive Vaccine Safety/Immunogenicity
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 Preventive Vaccine Safety
04/15/2011 Actemra tocilizumab Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) Biological response modifier Efficacy/Safety
04/15/2011 Actemra tocilizumab Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) Biological response modifier Safety/Pharmacokinetic
04/15/2011 Actemra tocilizumab Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) Biological response modifier Efficacy/Safety/Pharmacokinetic
04/15/2011 Actemra tocilizumab Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) Biological response modifier Efficacy/Safety/Pharmacokinetic
04/15/2011 Actemra tocilizumab Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) Biological response modifier Efficacy
04/06/2011 Invega paliperidone Treatment of schizophrenia Antipsychotic Safety
04/06/2011 Invega paliperidone Treatment of schizophrenia Antipsychotic Efficacy/Safety/Tolerability
04/06/2011 Invega paliperidone Treatment of schizophrenia Antipsychotic Safety/Pharmacokinetics
03/17/2011 Alimta pemetrexed disodium Refractory and recurrent solid tumors, including osteosarcoma, Ewing sarcoma/peripheral PNET, rhabdomyosarcoma, and neuroblastoma Antineoplastic Pharmacokinetic
03/17/2011 Alimta pemetrexed disodium Refractory and recurrent solid tumors, including osteosarcoma, Ewing sarcoma/peripheral PNET, rhabdomyosarcoma, and neuroblastoma Antineoplastic Efficacy/Safety
03/14/2011 Gadavist gadobutrol Detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system Medical imaging Safety/Pharmacokinetic/Tolerability
02/25/2011 Intuniv guanfacine Adjunctive treatment with long-acting oral psychostimulants for the treatment of ADHD Non-stimulant ADHD treatment Efficacy/Safety
02/17/2011 Hizentra Globulin Subcutaneous (Human), 20% Liquid * Postmarketing study Immune Serum Efficacy/Safety/Pharmacokinetic/Tolerability
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 Preventive Vaccine Safety/Immunogenicity
01/18/2011 Natroba spinosad Treatment of head lice infestation in patients 4 years of age and older Pediculocide, topical Pharmacokinetic/Tolerability
01/18/2011 Natroba spinosad Treatment of head lice infestation in patients 4 years of age and older Pediculocide, topical Pharmacokinetic/Tolerability
01/18/2011 Natroba spinosad Treatment of head lice infestation in patients 4 years of age and older Pediculocide, topical Efficacy/Safety
12/22/2010 GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant* Prevention of anal cancer caused by HPV types 16 and 18, and prevention of anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types included in the vaccine Preventive Vaccine Efficacy/Safety/Immunogenicity
12/21/2010 INOmax nitric oxide Prevention of bronchopulmonary dysplasia Pulmonary vasodilator Efficacy/Safety
12/21/2010 INOmax nitric oxide Prevention of bronchopulmonary dysplasia Pulmonary vasodilator Efficacy/Safety
12/21/2010 INOmax nitric oxide Prevention of bronchopulmonary dysplasia Pulmonary vasodilator Efficacy/Safety
12/15/2010 Uroxatral alfuzosin Elevated detrusor leak point pressure of neurologic origin Urology Pharmacokinetic
12/15/2010 Uroxatral alfuzosin Elevated detrusor leak point pressure of neurologic origin Urology Efficacy/Safety
12/15/2010 Uroxatral alfuzosin Elevated detrusor leak point pressure of neurologic origin Urology Efficacy/Safety
11/19/2010 Moxeza Ophthalmic Solution moxifloxacin Bacterial conjunctivitis Antibiotic Efficacy/Safety
11/19/2010 Moxeza Ophthalmic Solution moxifloxacin Bacterial conjunctivitis Antibiotic Efficacy/Safety
11/10/2010 Vyvanse Capsules lisdexamfetamine ADHD CNS Stimulant Efficacy/Safety
11/10/2010 Vyvanse Capsules lisdexamfetamine ADHD CNS Stimulant Efficacy/Safety
11/02/2010 Ofirmev acetaminophen Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever Analgesic; Antipyretic Efficacy/Safety/Tolerability
11/02/2010 Ofirmev acetaminophen Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever Analgesic; Antipyretic Safety/Pharmacokinetic
11/02/2010 Ofirmev acetaminophen Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever Analgesic; Antipyretic Safety
11/02/2010 Ofirmev acetaminophen Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever Analgesic; Antipyretic Efficacy
10/29/2010 Afinitor everolimus Treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis Antineoplastic Efficacy/Safety
10/05/2010 Aridol Powder for Inhalation mannitol Assessment of bronchial hyperresponsiveness in patients without clinically apparent asthma Diagnostic aid Efficacy/Safety
10/05/2010 Aridol Powder for Inhalation mannitol Assessment of bronchial hyperresponsiveness in patients without clinically apparent asthma Diagnostic aid Efficacy/Safety
10/05/2010 Aridol Powder for Inhalation mannitol Assessment of bronchial hyperresponsiveness in patients without clinically apparent asthma Diagnostic aid Pharmacokinetic/Pharmacodynamic
09/28/2010 Kapvay Extended Release Tablets clonidine Treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications Non-stimulant ADHD treatment Efficacy/Safety

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This information was extracted from various resources including the Medical and Clinical Pharmacology Reviews. Please note that there can be multiple numbers to describe each study, depending on the population of interest, including the number of patients randomized, enrolled, Intent to Treat (usually defined as the population of patients randomized that received at least one dose of study medication), modified Intend to Treat, and completed. Every effort is made to ensure the accuracy of this information. Data can only be provided if the information is provided by the sponsor. For instance, sponsor may report racial information using the categories suggested in the Guidance for Industry but they may use different categories. In addition, the ethnic data is not always provided for each study.

**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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