sábado, 18 de mayo 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 = 16
Total Number of Products Studied under Both = 1

DrugSponsorMedical ReviewClinical Pharmacology ReviewStatistical ReviewBPCA or PREA or Both
Darunavir - PrezistaJanssen Products, L.P.Medical (PDF -1MB)Clinical pharmacology (PDF -1MB)NonePREA
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 -606KB)None Statistical (PDF -211KB)PREA
Fluticasone propionate Lotion - CutivateFougera Pharmaceuticals Inc.Medical (PDF -3MB)Clinical pharmacology (PDF -1MB)Statistical (PDF -317MB)PREA
Fluticasone propionate/salmeterol xinafoate - Advair HFAGlaxoSmithKlineMedical (PDF -1 MB)Clinical pharmacology (PDF -267KB)Statistical (PDF -52KB)PREA
Iron Sucrose Injection, USP - VenoferLuitpold Pharmaceuticals, Inc.Medical (PDF -2MB)Clinical pharmacology (PDF -114KB)Statistical (PDF -376KB)PREA
Levonorgestrel-releasing intrauterine system - SkylaBayer HealthCare PharmaceuticalsMedical (PDF - 8MB)Clinical pharmacology (PDF - 3.5MB)Statistical (PDF - 248KB)PREA
Methylphenidate hydrochloride - Quillivant XRNextWave Pharmaceuticals, Inc.Medical (PDF -26KB)Clinical pharmacology (PDF -588KB)Statistical (PDF -380KB)PREA
Nevirapine - Viramune XRBoehringer Ingelheim Pharmaceuticals, Inc.Medical (PDF -2MB)Clinical pharmacology (PDF -446KB)Statistical (PDF -723KB)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 - FycompaEisai, Inc.Medical (PDF -4.8MB)Clinical pharmacology (PDF -6MB)Statistical (PDF -1.2MB)PREA
Phenylephrine hydrochloride ophthalmic solution  New!Paragon BioTeck, IncMedical (PDF -1.4MB)Clinical pharmacology (PDF -95KB)Statistical (PDF -1MB)PREA
Rabeprazole sodium - AcipHex SprinkleEisai Inc.Medical (PDF - 2MB)Clinical pharmacology (PDF - 4MB)Statistical (PDF 73KB)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
Saquinavir mesylate - InviraseHoffmann La-Roche, Incorporated c/o Genentech, Inc.Medical (PDF -1MB)Clinical pharmacology (PDF -1.5MB)Statistical (PDF -1MB)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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