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
| Drug | Sponsor | Medical Review | Clinical Pharmacology Review | Statistical Review | BPCA or PREA or Both |
|---|---|---|---|---|---|
| Darunavir - Prezista | Janssen Products, L.P. | Medical (PDF -1MB) | Clinical pharmacology (PDF -1MB) | None | PREA |
| Decitabine - Dacogen | Eisai Inc. | Medical (PDF -2MB) | Clinical pharmacology (PDF -1MB) | None | BPCA |
| Duloxetine hydrochloride - Cymbalta | Eli Lilly and Company | Medical (PDF -8MB) | Clinical pharmacology (PDF -959KB) | Statistical (PDF -665KB) | BPCA |
| Eszopiclone - Lunesta | Sunovion Pharmaceuticals, Inc. | Medical (PDF -1MB) | Clinical pharmacology (PDF -883KB) | None | BPCA |
| Everolimus tablets for oral suspension - Afinitor Disperz | Novartis Pharmaceuticals Corporation | Medical (PDF -10MB) | Clinical pharmacology (PDF -2MB) | Statistical (PDF -315KB) | BPCA |
| Fluticasone furoate - Veramyst | GlaxoSmithKline | Medical (PDF -606KB) | None | Statistical (PDF -211KB) | PREA |
| Fluticasone propionate Lotion - Cutivate | Fougera Pharmaceuticals Inc. | Medical (PDF -3MB) | Clinical pharmacology (PDF -1MB) | Statistical (PDF -317MB) | PREA |
| Fluticasone propionate/salmeterol xinafoate - Advair HFA | GlaxoSmithKline | Medical (PDF -1 MB) | Clinical pharmacology (PDF -267KB) | Statistical (PDF -52KB) | PREA |
| Iron Sucrose Injection, USP - Venofer | Luitpold Pharmaceuticals, Inc. | Medical (PDF -2MB) | Clinical pharmacology (PDF -114KB) | Statistical (PDF -376KB) | PREA |
| Levonorgestrel-releasing intrauterine system - Skyla | Bayer HealthCare Pharmaceuticals | Medical (PDF - 8MB) | Clinical pharmacology (PDF - 3.5MB) | Statistical (PDF - 248KB) | PREA |
| Methylphenidate hydrochloride - Quillivant XR | NextWave Pharmaceuticals, Inc. | Medical (PDF -26KB) | Clinical pharmacology (PDF -588KB) | Statistical (PDF -380KB) | PREA |
| Nevirapine - Viramune XR | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF -2MB) | Clinical pharmacology (PDF -446KB) | Statistical (PDF -723KB) | PREA |
| Oxcarbazepine - Oxtellar XR | Supernus Pharmaceuticals, Inc. | Medical (PDF -5MB) | Clinical pharmacology (PDF -7MB) | Statistical (PDF -482KB) | PREA |
| Pancrelipase - Creon | AbbVie Inc. | Medical (PDF -566KB) | None | None | PREA |
| Pancrelipase - Zenpep | Aptalis Pharma Limited. | Medical (PDF -587KB) | None | None | PREA |
| Perampanel - Fycompa | Eisai, Inc. | Medical (PDF -4.8MB) | Clinical pharmacology (PDF -6MB) | Statistical (PDF -1.2MB) | PREA |
Phenylephrine hydrochloride ophthalmic solution  | Paragon BioTeck, Inc | Medical (PDF -1.4MB) | Clinical pharmacology (PDF -95KB) | Statistical (PDF -1MB) | PREA |
| Rabeprazole sodium - AcipHex Sprinkle | Eisai Inc. | Medical (PDF - 2MB) | Clinical pharmacology (PDF - 4MB) | Statistical (PDF 73KB) | PREA |
| Risperidone - Risperdal Consta | Janssen Pharmaceuticals, Inc. | DD Summary Review (PDF -20KB) CTDL Review (PDF -1MB) Medical (PDF -670KB) Medical (PDF -667KB) | None | Statistical (PDF -237KB) | PREA |
| Saquinavir mesylate - Invirase | Hoffmann La-Roche, Incorporated c/o Genentech, Inc. | Medical (PDF -1MB) | Clinical pharmacology (PDF -1.5MB) | Statistical (PDF -1MB) | PREA |
| Sildenafil - Revatio | Pfizer, 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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