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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
12/24/2009 Famvir famciclovir Treatment of children 1 month  12 years of age w/ herpes simplex (HSV) & 1  12 years w/ varicella zoster (VSV) Antiviral Safety/Pharmacokinetic
12/22/2009 Flomax tamsulosin Treatment of elevated detrusor leak point pressure associated with neurological disorder Urology Efficacy/Safety/Pharmacokinetic
12/22/2009 Flomax tamsulosin Treatment of elevated detrusor leak point pressure associated with neurological disorder Urology Safety/Pharmacokinetic/Pharmacodynamic
12/22/2009 Topamax topiramate Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 months Anticonvulsant Efficacy/Safety
12/22/2009 Topamax topiramate Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 months Anticonvulsant Pharmacokinetic/Tolerability
12/22/2009 Topamax topiramate Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 months Anticonvulsant Safety/Pharmacokinetic/Tolerability
12/14/2009 Daytrana methylphenidate Postmarketing safety study CNS Stimulant Safety
12/02/2009 Seroquel quetiapine Treatment of schizophrenia in adolescents 13 to 17 years of age and the treatment of bipolar mania in children and adolescents 10 to 17 years of age Antipsychotic Safety/Pharmacokinetic/Tolerability
12/02/2009 Seroquel quetiapine Treatment of schizophrenia in adolescents 13 to 17 years of age and the treatment of bipolar mania in children and adolescents 10 to 17 years of age Antipsychotic Efficacy/Safety
12/02/2009 Seroquel quetiapine Treatment of schizophrenia in adolescents 13 to 17 years of age and the treatment of bipolar mania in children and adolescents 10 to 17 years of age Antipsychotic Efficacy/Safety
12/02/2009 Seroquel quetiapine Treatment of schizophrenia in adolescents 13 to 17 years of age and the treatment of bipolar mania in children and adolescents 10 to 17 years of age Antipsychotic Safety/Tolerability
12/01/2009 Patanase olopatadine Seasonal allergic rhinitis Antihistamine Efficacy/Safety 6 to <12 years
12/01/2009 Patanase olopatadine Seasonal allergic rhinitis Antihistamine Safety/Pharmacokinetic in 2 to <6 years
11/19/2009 Abilify aripiprazole Irritability associated with autistic disorder Antipsychotic Efficacy/Safety/Tolerability
11/19/2009 Abilify aripiprazole Irritability associated with autistic disorder Antipsychotic Efficacy/Safety/Tolerability
11/12/2009 Protonix pantoprazole GERD Antiulcerative Safety/Pharmacokinetic/Pharmacodynamic
11/12/2009 Protonix pantoprazole GERD Antiulcerative Efficacy/Safety/Pharmacokinetic
11/12/2009 Protonix pantoprazole GERD Antiulcerative Efficacy/Safety
11/12/2009 Protonix pantoprazole GERD Antiulcerative Safety/Pharmacokinetic/Pharmacodynamic
11/12/2009 Protonix pantoprazole GERD Antiulcerative Safety/Pharmacokinetic
11/10/2009 AFLURIA Influenza Virus Vaccine* Active immunization for the prevention of influenza disease caused by virus types A and B contained in the vaccine Preventive Vaccine Safety/Immunogenicity
10/23/2009 Focalin XR dexmethylphenidate ADHD CNS Stimulant Efficacy/Safety/Tolerability
10/22/2009 Atacand candesartan Hypertension Antihypertensive Efficacy/Safety/Pharmacokinetic
10/22/2009 Atacand candesartan Hypertension Antihypertensive Efficacy/Safety/Pharmacokinetic
10/22/2009 Atacand candesartan Hypertension Antihypertensive Efficacy/Safety/Pharmacokinetic
10/19/2009 Fluarix Influenza Virus Vaccine* Active immunization for the prevention of influenza disease caused by virus types A and B contained in the vaccine Preventive Vaccine Safety/Immunogenicity
10/16/2009 CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant* Prevention of genital warts caused by HPV 16 and 18 Preventive Vaccine Safety/Immunogenicity
10/16/2009 CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant* Prevention of genital warts caused by HPV 16 and 18 Preventive Vaccine Safety/Immunogenicity
10/16/2009 CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant* Prevention of genital warts caused by HPV 16 and 18 Preventive Vaccine Efficacy/Safety/Immunogenicity
10/16/2009 CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant* Prevention of genital warts caused by HPV 16 and 18 Preventive Vaccine Efficacy/Safety/Immunogenicity
10/16/2009 GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant* Prevention of genital warts caused by HPV 6 and 11 Preventive Vaccine Safety/Immunogenicity
10/15/2009 Crestor rosuvastatin Heterozygous familial hypercholesterolemia Antilipemic Efficacy/Safety
10/02/2009 Welchol colesevelam Heterozygous familial hypercholesterolemia Antilipemic Efficacy/Safety
09/08/2009 Bepreve Ophthalmic Solution bepotastine besilate Ocular itching associated with allergic conjunctivitis Antihistamine, topical Safety
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Efficacy/Safety
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Pharmacokinetic
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Safety/Pharmacokinetic/Tolerability
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Efficacy/Safety/Pharmacokinetic/Pharmacodynamic/Tolerability
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Safety/Tolerability
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Efficacy/Safety/Tolerability
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Efficacy/Safety
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Efficacy/Safety/Tolerability
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Efficacy/Safety/Tolerability
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Efficacy/Safety
08/31/2009 Astepro Nasal Spray azelastine hydrochloride Seasonal and perennial allergic rhinitis in patients 12 years of age and older. Antihistamine Efficacy/Safety
08/31/2009 Astepro Nasal Spray azelastine hydrochloride Seasonal and perennial allergic rhinitis in patients 12 years of age and older. Antihistamine Efficacy/Safety
08/31/2009 Astepro Nasal Spray azelastine hydrochloride Seasonal and perennial allergic rhinitis in patients 12 years of age and older. Antihistamine Efficacy/Safety
08/31/2009 Astepro Nasal Spray azelastine hydrochloride Seasonal and perennial allergic rhinitis in patients 12 years of age and older. Antihistamine Efficacy/Safety
08/31/2009 Astepro Nasal Spray azelastine hydrochloride Seasonal and perennial allergic rhinitis in patients 12 years of age and older. Antihistamine Efficacy/Safety
08/31/2009 Astepro Nasal Spray azelastine hydrochloride Seasonal and perennial allergic rhinitis in patients 12 years of age and older. Antihistamine 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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