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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
12/17/2008 Epiduo adapalene and benzoyl peroxide Topical treatment of acne vulgaris in patients 12 years of age and older Antiacne, topical Efficacy/Safety
12/11/2008 PegIntron Peginterferon alfa-2b Co-administered with ritonavir to treat chronic hepatitis C in patients 3 years of age and older with compensated liver disease previously untreated with interferon alpha Antiviral Efficacy/Safety/Pharmacokinetic/Tolerability
12/05/2008 Arimidex anastrozole Male pubertal patients with gynecomastia and female pediatric patients with McCune-Albright syndrome with progressive precocious puberty Estrogen lowering agent Pharmacokinetic/Pharmacodynamic
12/05/2008 Arimidex anastrozole Male pubertal patients with gynecomastia and female pediatric patients with McCune-Albright syndrome with progressive precocious puberty Estrogen lowering agent Efficacy/Safety
12/05/2008 Arimidex anastrozole Male pubertal patients with gynecomastia and female pediatric patients with McCune-Albright syndrome with progressive precocious puberty Estrogen lowering agent Efficacy/Safety
12/05/2008 Arimidex anastrozole Male pubertal patients with gynecomastia and female pediatric patients with McCune-Albright syndrome with progressive precocious puberty Estrogen lowering agent Pharmacokinetic
11/14/2008 Neulasta Pefilgrastim Decrease the incidence of infection in pediatric patients with sarcoma Hematopoietic Safety/Pharmacokinetic
10/28/2008 Prevacid lansoprazole Symptomatic GERD in infants Antiulcerative Efficacy/Safety/Pharmacokinetic
10/24/2008 Apidra insulin glulisine recombinant Diabetes Mellitus Antidiabetic Efficacy/Safety
10/24/2008 Apidra insulin glulisine recombinant Diabetes Mellitus Antidiabetic Safety/Pharmacokinetic/Pharmacodynamic
10/21/2008 Acanya Gel clindamycin/ benzoyl peroxide combination Acne vulgaris in patients 12 years of age and older Antiacne, topical Other
10/21/2008 Acanya Gel clindamycin/ benzoyl peroxide combination Acne vulgaris in patients 12 years of age and older Antiacne, topical Efficacy/Safety
10/21/2008 Acanya Gel clindamycin/ benzoyl peroxide combination Acne vulgaris in patients 12 years of age and older Antiacne, topical Efficacy/Safety
10/21/2008 Acanya Gel clindamycin/ benzoyl peroxide combination Acne vulgaris in patients 12 years of age and older Antiacne, topical Efficacy/Safety
10/10/2008 Kogenate FS Antihemophilic Factor (Recombinant)* Routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage Hematology/Coagulation Efficacy/Safety
09/19/2008 Nasacort AQ triamcinolone Treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older Anti-inflammatory, topical Safety
09/19/2008 Nasacort AQ triamcinolone Treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older Anti-inflammatory, topical Safety/Pharmacokinetic
09/19/2008 Nasacort AQ triamcinolone Treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older Anti-inflammatory, topical Efficacy/Safety
09/12/2008 GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant* Prevention of vulvar and vaginal cancer caused by HPV types 16 and 18 Preventive Vaccine Efficacy/Safety/Immunogenicity
09/03/2008 Valtrex valacyclovir Chickenpox; active or at risk for herpes virus infection Antiviral Safety/Pharmacokinetic/Tolerability
09/03/2008 Valtrex valacyclovir Chickenpox; active or at risk for herpes virus infection Antiviral Safety/Pharmacokinetic/Tolerability
09/03/2008 Valtrex valacyclovir Chickenpox; active or at risk for herpes virus infection Antiviral Safety/Pharmacokinetic/Tolerability
08/28/2008 Zemuron rocuronium Adjunct to general anesthesia Anesthetic agent Efficacy/Safety
08/28/2008 Zemuron rocuronium Adjunct to general anesthesia Anesthetic agent Safety/Pharmacokinetic/Pharmacodynamic
08/14/2008 Zyprexa olanzapine schizophrenia; bipolar disorder Antipsychotic Efficacy/Safety
08/14/2008 Zyprexa olanzapine schizophrenia; bipolar disorder Antipsychotic Pharmacokinetic
08/14/2008 Zyprexa olanzapine schizophrenia; bipolar disorder Antipsychotic Safety/Pharmacokinetic
08/14/2008 Zyprexa olanzapine schizophrenia; bipolar disorder Antipsychotic Pharmacokinetic
08/14/2008 Zyprexa olanzapine schizophrenia; bipolar disorder Antipsychotic Efficacy/Safety
08/14/2008 Zyprexa olanzapine schizophrenia; bipolar disorder Antipsychotic Efficacy/Safety
07/29/2008 Cancidas caspofungin Empirical therapy for presumed fungal infections in febrile, neutropenic patients; Candidemia and certain Candida infections; Esophageal Candidiasis; Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies Antifungal Safety/Pharmacokinetic
07/29/2008 Cancidas caspofungin Empirical therapy for presumed fungal infections in febrile, neutropenic patients; Candidemia and certain Candida infections; Esophageal Candidiasis; Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies Antifungal Safety/Pharmacokinetic/Tolerability (2/3)
07/29/2008 Cancidas caspofungin Empirical therapy for presumed fungal infections in febrile, neutropenic patients; Candidemia and certain Candida infections; Esophageal Candidiasis; Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies Antifungal Safety/Pharmacokinetic/Tolerability (3/3)
07/29/2008 Cancidas caspofungin Empirical therapy for presumed fungal infections in febrile, neutropenic patients; Candidemia and certain Candida infections; Esophageal Candidiasis; Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies Antifungal Efficacy/Safety/Tolerability
07/29/2008 Cancidas caspofungin Empirical therapy for presumed fungal infections in febrile, neutropenic patients; Candidemia and certain Candida infections; Esophageal Candidiasis; Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies Antifungal Efficacy/Safety/Tolerability
07/01/2008 Flovent HFA fluticasone propionate Asthma in < 4 years Antiasthmatic Safety/Pharmacokinetic/Pharmacodynamic/Tolerability
06/30/2008 Aciphex rabeprazole Gastroesophageal reflux in adolescent patients 12 years of age and above Antiulcerative Efficacy/Safety
06/30/2008 Aciphex rabeprazole Gastroesophageal reflux in adolescent patients 12 years of age and above Antiulcerative Pharmacokinetic
06/24/2008 KINRIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine* Active immunization against diphtheria, tetanus, pertussis, & poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series when previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX and for the first three doses and INFANRIX for the fourth dose Preventive Vaccine Safety/Immunogenicity
06/24/2008 KINRIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine* Active immunization against diphtheria, tetanus, pertussis, & poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series when previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX and for the first three doses and INFANRIX for the fourth dose Preventive Vaccine Safety/Immunogenicity
06/24/2008 KINRIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine* Active immunization against diphtheria, tetanus, pertussis, & poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series when previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX and for the first three doses and INFANRIX for the fourth dose Preventive Vaccine Safety/Immunogenicity
06/24/2008 Viramune Tablets 200 mg Viramune Oral Suspension 10 mg/mL nevirapine Use in combination with other antiretroviral agents for the treatment of HIV-1 infection Antiviral Safety/Pharmacokinetic/Tolerability
06/23/2008 Aptivus tipranavir Co-administered with ritonavir for combination antiretroviral in patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor Antiviral Safety/Pharmacokinetic/Tolerability
06/20/2008 Kaletra lopinavir/ ritonavir Use in combination with other antiretroviral agents for HIV-1 infection Antiviral Safety/Pharmacokinetic/Tolerability
06/20/2008 Kaletra lopinavir/ ritonavir Use in combination with other antiretroviral agents for HIV-1 infection Antiviral Efficacy/Safety/Pharmacokinetic/Tolerability
06/20/2008 Kaletra lopinavir/ ritonavir Use in combination with other antiretroviral agents for HIV-1 infection Antiviral Efficacy/Safety/Pharmacokinetic/Tolerability
06/20/2008 Pentacel Diphtheria And Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine* Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b Preventive Vaccine Safety/Immunogenicity
06/20/2008 Pentacel Diphtheria And Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine* Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b Preventive Vaccine Safety/Immunogenicity
06/20/2008 Pentacel Diphtheria And Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine* Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b Preventive Vaccine Safety/Immunogenicity
06/20/2008 Pentacel Diphtheria And Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine* Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b Preventive Vaccine Safety/Immunogenicity

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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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