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 = 13
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. | Medical1 (PDF -1MB) | Clinical pharmacology2 (PDF -1MB) | None | PREA |
| Decitabine - Dacogen | Eisai Inc. | Medical3 (PDF -2MB) | Clinical pharmacology4 (PDF -1MB) | None | BPCA |
| Duloxetine hydrochloride - Cymbalta | Eli Lilly and Company | Medical5 (PDF -8MB) | Clinical pharmacology6 (PDF -959KB) | Statistical7 (PDF -665KB) | BPCA |
| Eszopiclone - Lunesta | Sunovion Pharmaceuticals, Inc. | Medical8 (PDF -1MB) | Clinical pharmacology9 (PDF -883KB) | None | BPCA |
| Everolimus tablets for oral suspension - Afinitor Disperz | Novartis Pharmaceuticals Corporation | Medical10 (PDF -10MB) | Clinical pharmacology11 (PDF -2MB) | Statistical12 (PDF -315KB) | BPCA |
| Fluticasone furoate - Veramyst | GlaxoSmithKline | Medical13 (PDF -606KB) | None | Statistical14 (PDF -211KB) | PREA |
| Fluticasone propionate Lotion - Cutivate | Fougera Pharmaceuticals Inc. | Medical15 (PDF -3MB) | Clinical pharmacology16 (PDF -1MB) | Statistical17 (PDF -317MB) | PREA |
| Fluticasone propionate/salmeterol xinafoate - Advair HFA | GlaxoSmithKline | Medical 18(PDF -1 MB) | Clinical pharmacology19 (PDF -267KB) | Statistical20 (PDF -52KB) | PREA |
| Iron Sucrose Injection, USP - Venofer | Luitpold Pharmaceuticals, Inc. | Medical21 (PDF -2MB) | Clinical pharmacology22 (PDF -114KB) | Statistical23 (PDF -376KB) | PREA |
| Methylphenidate hydrochloride - Quillivant XR | NextWave Pharmaceuticals, Inc. | Medical24 (PDF -26KB) | Clinical pharmacology25 (PDF -588KB) | Statistical26 (PDF -380KB) | PREA |
| Nevirapine - Viramune XR | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical27 (PDF -2MB) | Clinical pharmacology28 (PDF -446KB) | Statistical29 (PDF -723KB) | PREA |
| Oxcarbazepine - Oxtellar XR | Supernus Pharmaceuticals, Inc. | Medical30 (PDF -5MB) | Clinical pharmacology31 (PDF -7MB) | Statistical32 (PDF -482KB) | PREA |
| Pancrelipase - Creon | AbbVie Inc. | Medical33 (PDF -566KB) | None | None | PREA |
| Pancrelipase - Zenpep | Aptalis Pharma Limited. | Medical34 (PDF -587KB) | None | None | PREA |
| Perampanel - Fycompa | Eisai, Inc. | Medical35 (PDF -4.8MB) | Clinical pharmacology36 (PDF -6MB) | Statistical37 (PDF -1.2MB) | PREA |
| Risperidone - Risperdal Consta | Janssen Pharmaceuticals, Inc. | DD Summary Review38 (PDF -20KB) CTDL Review39 (PDF -1MB) Medical40 (PDF -670KB) Medical41 (PDF -667KB) | None | Statistical42 (PDF -237KB) | PREA |
| Saquinavir mesylate - Invirase | Hoffmann La-Roche, Incorporated c/o Genentech, Inc. | Medical43 (PDF -1MB) | Clinical pharmacology44 (PDF -1.5MB) | Statistical45 (PDF -1MB) | PREA |
| Sildenafil - Revatio | Pfizer, Inc. | Medical46 (PDF -6MB) | Clinical pharmacology47 (PDF -2MB) | Statistical48 (PDF -508KB) | BOTH |
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