viernes, 14 de diciembre de 2012

Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Amendments Act of 2012 (FDASIA)

 

Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Amendments Act of 2012 (FDASIA)

In accordance with section 505A(k)(1) of the Act (Best Pharmaceuticals for Children Act of 2012 (BPCA)) and section 505B(h)(1) of the Act (Pediatric Research Equity Act of 2012 (PREA)), as amended by FDASIA (Public Law 112-144), the following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.
Total Number of Products Studied under BPCA = 4
Total Number of Products Studied under PREA = 8
Total Number of Products Studied under Both = 1

DrugSponsorMedical ReviewClinical Pharmacology ReviewStatistical ReviewBPCA or PREA or Both
Decitabine - Dacogen Eisai Inc.Medical (PDF -2MB)Clinical pharmacology (PDF -1MB)NoneBPCA
Duloxetine hydrochloride - CymbaltaEli Lilly and CompanyMedical (PDF -8MB)Clinical pharmacology (PDF -959KB)Statistical (PDF -665KB)BPCA
Eszopiclone - LunestaSunovion Pharmaceuticals, Inc.Medical (PDF -1MB)Clinical pharmacology (PDF -883KB)NoneBPCA
Everolimus tablets for oral suspension - Afinitor DisperzNovartis Pharmaceuticals CorporationMedical (PDF -10MB)Clinical pharmacology (PDF -2MB)Statistical (PDF -315KB)BPCA
Fluticasone furoate - VeramystGlaxoSmithKlineMedical (PDF -606 KB)None Statistical (PDF -211KB)PREA
Fluticasone propionate Lotion - CutivateFougera Pharmaceuticals Inc.Medical (PDF -3MB)Clinical pharmacology (PDF -1MB)Statistical (PDF -317MB)PREA
Iron Sucrose Injection, USP - VenoferLuitpold Pharmaceuticals, Inc.Medical (PDF -2MB)Clinical pharmacology (PDF -114KB)Statistical (PDF -376KB)PREA
Methylphenidate hydrochloride - Quillivant XRNextWave Pharmaceuticals, Inc.Medical (PDF -26KB)Clinical pharmacology (PDF -588KB)Statistical (PDF -380KB)PREA
Oxcarbazepine - Oxtellar XRSupernus Pharmaceuticals, Inc.Medical (PDF -5MB)Clinical pharmacology (PDF -7MB)Statistical (PDF -482KB)PREA
Pancrelipase - CreonAbbVie Inc.Medical (PDF -566KB)NoneNonePREA
Pancrelipase - ZenpepAptalis Pharma Limited.Medical (PDF -587KB)NoneNonePREA
Perampanel - Fycompa New!Eisai, Inc.Medical (PDF -4.8MB)Clinical pharmacology (PDF -5.9MB)Statistical (PDF -1.2MB)PREA
Risperidone - Risperdal ConstaJanssen Pharmaceuticals, Inc.DD Summary Review (PDF -20KB)
CTDL Review (PDF -1MB)
Medical (PDF -670KB)
Medical (PDF -667KB)
NoneStatistical (PDF -237KB)PREA
Sildenafil - RevatioPfizer, Inc.Medical (PDF -6MB)Clinical pharmacology (PDF -2MB)Statistical (PDF -508KB)BOTH

Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)

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