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 = 4Total Number of Products Studied under PREA = 11
Total Number of Products Studied under Both = 1
| Drug | Sponsor | Medical Review | Clinical Pharmacology Review | Statistical Review | BPCA or PREA or Both |
|---|---|---|---|---|---|
| Decitabine - Dacogen | Eisai Inc. | Medical1 (PDF -2MB) | Clinical pharmacology2 (PDF -1MB) | None | BPCA |
| Duloxetine hydrochloride - Cymbalta | Eli Lilly and Company | Medical3 (PDF -8MB) | Clinical pharmacology4 (PDF -959KB) | Statistical5 (PDF -665KB) | BPCA |
| Eszopiclone - Lunesta | Sunovion Pharmaceuticals, Inc. | Medical6 (PDF -1MB) | Clinical pharmacology7 (PDF -883KB) | None | BPCA |
| Everolimus tablets for oral suspension - Afinitor Disperz | Novartis Pharmaceuticals Corporation | Medical8 (PDF -10MB) | Clinical pharmacology9 (PDF -2MB) | Statistical10 (PDF -315KB) | BPCA |
| Fluticasone furoate - Veramyst | GlaxoSmithKline | Medical11 (PDF -606KB) | None | Statistical12 (PDF -211KB) | PREA |
| Fluticasone propionate Lotion - Cutivate | Fougera Pharmaceuticals Inc. | Medical13 (PDF -3MB) | Clinical pharmacology14 (PDF -1MB) | Statistical15 (PDF -317MB) | PREA |
| Iron Sucrose Injection, USP - Venofer | Luitpold Pharmaceuticals, Inc. | Medical16 (PDF -2MB) | Clinical pharmacology17 (PDF -114KB) | Statistical18 (PDF -376KB) | PREA |
| Methylphenidate hydrochloride - Quillivant XR | NextWave Pharmaceuticals, Inc. | Medical19 (PDF -26KB) | Clinical pharmacology20 (PDF -588KB) | Statistical21 (PDF -380KB) | PREA |
Nevirapine - Viramune XR  | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical22 (PDF -2MB) | Clinical pharmacology23 (PDF -446KB) | Statistical24 (PDF -723KB) | PREA |
| Oxcarbazepine - Oxtellar XR | Supernus Pharmaceuticals, Inc. | Medical25 (PDF -5MB) | Clinical pharmacology26 (PDF -7MB) | Statistical27 (PDF -482KB) | PREA |
| Pancrelipase - Creon | AbbVie Inc. | Medical28 (PDF -566KB) | None | None | PREA |
| Pancrelipase - Zenpep | Aptalis Pharma Limited. | Medical29 (PDF -587KB) | None | None | PREA |
| Perampanel - Fycompa | Eisai, Inc. | Medical30 (PDF -4.8MB) | Clinical pharmacology31 (PDF -6MB) | Statistical32 (PDF -1.2MB) | PREA |
| Risperidone - Risperdal Consta | Janssen Pharmaceuticals, Inc. | DD Summary Review33 (PDF -20KB) CTDL Review34 (PDF -1MB) Medical35 (PDF -670KB) Medical36 (PDF -667KB) | None | Statistical37 (PDF -237KB) | PREA |
| Saquinavir mesylate - Invirase | Hoffmann La-Roche, Incorporated c/o Genentech, Inc. | Medical38 (PDF -1MB) | Clinical pharmacology39 (PDF -1.5MB) | Statistical40 (PDF -1MB) | PREA |
| Sildenafil - Revatio | Pfizer, Inc. | Medical41 (PDF -6MB) | Clinical pharmacology42 (PDF -2MB) | Statistical43 (PDF -508KB) | BOTH |
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