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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.
Download Pediatric Studies Characteristics 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:  397
Approval Date Trade Name Generic or Proper Name (*) Indications Studied Therapeutic Category Study Type
12/14/2012 Fluarix Quadrivalent Influenza Virus Vaccine* Include a quadrivalent influenza virus vaccine formulation (Fluarix® Quadrivalent) Vaccine Safety/Immunogenicity
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Safety
05/01/2012 Dymista azelastine hydrochloride and fluticasone proprionate Relief of symptoms of seasonal allergic rhinitis antihistamine; anti-inflammatory Efficacy/Safety
05/01/2012 Dymista azelastine hydrochloride and fluticasone proprionate Relief of symptoms of seasonal allergic rhinitis antihistamine; anti-inflammatory Efficacy/Safety
05/01/2012 Dymista azelastine hydrochloride and fluticasone proprionate Relief of symptoms of seasonal allergic rhinitis antihistamine; anti-inflammatory Efficacy/Safety
05/01/2012 Dymista azelastine hydrochloride and fluticasone proprionate Relief of symptoms of seasonal allergic rhinitis antihistamine; anti-inflammatory Efficacy/Safety
05/01/2012 Dymista azelastine hydrochloride and fluticasone proprionate Relief of symptoms of seasonal allergic rhinitis antihistamine; anti-inflammatory Efficacy/Safety/Tolerability
03/26/2012 Intelence etravirine Treatment of HIV-1 infection in combination with other antiretroviral agents Antiviral Safety/Pharmacokinetic
03/26/2012 Singulair Oral Granules, Tablets, and Chewable Tablets montelukast Prevention of exercise-induced bronchoconstriction Antiasthmatic Efficacy/Safety/Tolerability
03/26/2012 Intelence etravirine Treatment of HIV-1 infection in combination with other antiretroviral agents Antiviral Efficacy/Safety/Tolerability
03/23/2012 QNASL beclomethasone dipropionate Treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis Anti-inflammatory, topical Efficacy/Safety/Tolerability
03/23/2012 QNASL QNASL beclomethasone dipropionate Treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis Anti-inflammatory, topical Efficacy/Safety/Tolerability
03/23/2012 QNASL beclomethasone dipropionate Treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis Anti-inflammatory, topical Efficacy/Safety/Tolerability
03/23/2012 QNASL beclomethasone dipropionate Treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis Anti-inflammatory, topical Efficacy/Safety/Tolerability
03/23/2012 QNASL beclomethasone dipropionate Treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis Anti-inflammatory, topical Efficacy/Safety/Tolerability
03/01/2012 Ultresa pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
02/29/2012 FluMist Quadrivalent Influenza Vaccine Live, Intranasal* Active immunization for the prevention of disease caused by influenza Vaccine Efficacy/Safety/Immunogenicity
02/09/2012 Famvir famciclovir Recurrent herpes labialis Antiviral Efficacy/Safety/Pharmacokinetic
02/07/2012 Sklice ivermectin ivermectin Topical treatment of head lice infestations Pediculocide, topical Efficacy/Safety/Tolerability
02/07/2012 Sklice ivermectin Topical treatment of head lice infestations Pediculocide, topical Safety/Pharmacokinetic/Pharmacodynamic/Tolerability
02/07/2012 Sklice ivermectin Topical treatment of head lice infestations Pediculocide, topical Efficacy/Safety/Tolerability
02/07/2012 Sklice ivermectin Topical treatment of head lice infestations Topical treatment of head lice infestations Pediculocide, topical Efficacy/Safety/Tolerability
02/07/2012 Sklice ivermectin Topical treatment of head lice infestations Pediculocide, topical Efficacy/Safety/Tolerability
02/07/2012 Sklice ivermectin Topical treatment of head lice infestations Pediculocide, topical Efficacy/Safety/Pharmacokinetic/Tolerability
01/25/2012 TISSEEL Fibrin Sealant* Hemostasis: An adjunct to hemostasis in patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: An adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies Wound healing Efficacy/Safety
01/18/2012 Viread tenofovir disoproxil fumarate Treatment of HIV infection in combination with other antiretroviral agents Antiviral Safety/Pharmacokinetic
01/18/2012 Viread tenofovir disoproxil fumarate Treatment of HIV infection in combination with other antiretroviral agents Antiviral Efficacy/Safety
12/21/2011 Isentress raltegravir In combination with other antiretroviral agents for the treatment of HIV-1 infection Antiviral Efficacy/Safety/Pharmacokinetic/Tolerability
12/16/2011 Maxalt and Maxalt-MLT rizatriptan Treatment of migraine Antimigraine Safety/Pharmacokinetic/Tolerability
12/16/2011 Maxalt and Maxalt-MLT rizatriptan Treatment of migraine Antimigraine Efficacy/Safety
12/16/2011 Maxalt and Maxalt-MLT rizatriptan Treatment of migraine Antimigraine Safety
12/16/2011 Prezista darunavir Treatment of HIV-1 infection in adults and pediatric patients 3 years of age and older and weighing at least 10 kg Antiviral Safety/Pharmacokinetic/Pharmacodynamic/Tolerability
12/15/2011 Nexium esomeprazole Erosive esophagitis due to acid-mediated gastroesophageal reflux disease Antiulcerative Pharmacokinetic/Pharmacodynamic
12/14/2011 Advate Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method* Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with hemophilia A Antihemophilic Factor Efficacy/Safety/Pharmacokinetic
11/10/2011 HEMACORD hematopoietic progenitor cells, cord blood* For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment Somatic Cell Study summary pending
11/10/2011 HEMACORD hematopoietic progenitor cells, cord blood* For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment Somatic Cell Efficacy/Safety
11/10/2011 HEMACORD hematopoietic progenitor cells, cord blood* For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment Somatic Cell Efficacy/Safety
11/10/2011 HEMACORD hematopoietic progenitor cells, cord blood* For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment Somatic Cell Efficacy/Safety
11/09/2011 Chantix varenicline Smoking cessation Smoking cessation Safety/Pharmacokinetic/Tolerability
10/18/2011 Ixempra Kit ixabepilone Advanced or refractory solid tumors Antineoplastic Safety/Pharmacokinetic
10/18/2011 Ixempra Kit ixabepilone Advanced or refractory solid tumors Antineoplastic Efficacy/Safety
10/17/2011 Reyataz atazanavir Treatment of HIV - 1 infection Antiviral Safety/Pharmacokinetic
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 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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