martes, 29 de enero de 2013

Development Resources > 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)

Development Resources > 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 = 11
Total Number of Products Studied under Both = 1

DrugSponsorMedical ReviewClinical Pharmacology ReviewStatistical ReviewBPCA or PREA or Both
Decitabine - Dacogen Eisai Inc.Medical1 (PDF -2MB)Clinical pharmacology2 (PDF -1MB)NoneBPCA
Duloxetine hydrochloride - CymbaltaEli Lilly and CompanyMedical3 (PDF -8MB)Clinical pharmacology4 (PDF -959KB)Statistical5 (PDF -665KB)BPCA
Eszopiclone - LunestaSunovion Pharmaceuticals, Inc.Medical6 (PDF -1MB)Clinical pharmacology7 (PDF -883KB)NoneBPCA
Everolimus tablets for oral suspension - Afinitor DisperzNovartis Pharmaceuticals CorporationMedical8 (PDF -10MB)Clinical pharmacology9 (PDF -2MB)Statistical10 (PDF -315KB)BPCA
Fluticasone furoate - VeramystGlaxoSmithKlineMedical11 (PDF -606KB)None Statistical12 (PDF -211KB)PREA
Fluticasone propionate Lotion - CutivateFougera Pharmaceuticals Inc.Medical13 (PDF -3MB)Clinical pharmacology14 (PDF -1MB)Statistical15 (PDF -317MB)PREA
Iron Sucrose Injection, USP - VenoferLuitpold Pharmaceuticals, Inc.Medical16 (PDF -2MB)Clinical pharmacology17 (PDF -114KB)Statistical18 (PDF -376KB)PREA
Methylphenidate hydrochloride - Quillivant XRNextWave Pharmaceuticals, Inc.Medical19 (PDF -26KB)Clinical pharmacology20 (PDF -588KB)Statistical21 (PDF -380KB)PREA
Nevirapine - Viramune XR New!Boehringer Ingelheim Pharmaceuticals, Inc.Medical22 (PDF -2MB)Clinical pharmacology23 (PDF -446KB)Statistical24 (PDF -723KB)PREA
Oxcarbazepine - Oxtellar XRSupernus Pharmaceuticals, Inc.Medical25 (PDF -5MB)Clinical pharmacology26 (PDF -7MB)Statistical27 (PDF -482KB)PREA
Pancrelipase - CreonAbbVie Inc.Medical28 (PDF -566KB)NoneNonePREA
Pancrelipase - ZenpepAptalis Pharma Limited.Medical29 (PDF -587KB)NoneNonePREA
Perampanel - FycompaEisai, Inc.Medical30 (PDF -4.8MB)Clinical pharmacology31 (PDF -6MB)Statistical32 (PDF -1.2MB)PREA
Risperidone - Risperdal ConstaJanssen Pharmaceuticals, Inc.DD Summary Review33 (PDF -20KB)
CTDL Review34 (PDF -1MB)
Medical35 (PDF -670KB)
Medical36 (PDF -667KB)
NoneStatistical37 (PDF -237KB)PREA
Saquinavir mesylate - Invirase New!Hoffmann La-Roche, Incorporated c/o Genentech, Inc.Medical38 (PDF -1MB)Clinical pharmacology39 (PDF -1.5MB)Statistical40 (PDF -1MB)PREA
Sildenafil - RevatioPfizer, Inc.Medical41 (PDF -6MB)Clinical pharmacology42 (PDF -2MB)Statistical43 (PDF -508KB)BOTH


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