Drugs
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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 = 7
Total Number of Products Studied under PREA = 21
Total Number of Products Studied under Both = 1
| Drug | Sponsor | Medical Review | Clinical Pharmacology Review | Statistical Review | BPCA or PREA or Both |
|---|---|---|---|---|---|
| Adapalene and benzoyl peroxide - Epiduo | Galderma Laboratories, LP | Medical (PDF -2.2MB) | Clinical pharmacology (PDF -124KB) | Statistical (PDF -577KB) | PREA |
| 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 |
| Difluprednate ophthalmic emulsion - Durezol | Alcon Pharmaceuticals Ltd. c/o Alcon Research Ltd | Medical (PDF -748KB) | Clinical pharmacology (PDF -40KB) | Statistical (PDF -479KB) | BPCA |
| Duloxetine hydrochloride - Cymbalta | Eli Lilly and Company | Medical (PDF -8MB) | Clinical pharmacology (PDF -959KB) | Statistical (PDF -665KB) | BPCA |
Efavirenz - Sustiva  |
Bristol-Myers Squibb Company | Medical (PDF -1.9MB) | Clinical pharmacology (PDF -9.3MB) | None | BPCA |
| Eszopiclone - Lunesta | Sunovion Pharmaceuticals, Inc. | Medical (PDF -1MB) | Clinical pharmacology (PDF -883KB) | None | BPCA |
| Etravirine - Intelence | Janssen Products, L.P. | Medical (PDF -1.4MB) | Clinical pharmacology (PDF -1.7MB) | None | PREA |
| 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 |
| Gadoterate meglumine - Dotarem | Guerbet LLC | Medical (PDF -3MB) | Clinical pharmacology (PDF -768KB) | Statistical (PDF -1.2MB) | PREA |
| Iron Sucrose Injection, USP - Venofer | Luitpold Pharmaceuticals, Inc. | Medical (PDF -2MB) | Clinical pharmacology (PDF -114KB) | Statistical (PDF -376KB) | PREA |
| Levonorgestrel/ethinyl estradiol and ethinyl estradiol - Quartette | Teva Branded Pharmaceutical Products R&D, Inc. | Medical (PDF -6MB) | Clinical pharmacology (PDF -4MB) ) Clinpharm addendum (PDF - 89KB) |
Statistical (PDF -1MB) | PREA |
| Levonorgestrel-releasing intrauterine system - Skyla | Bayer HealthCare Pharmaceuticals, Inc. | Medical (PDF - 8MB) | Clinical pharmacology (PDF - 4MB) | Statistical (PDF - 424KB) | 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 | Eisa Inc. | Medical (PDF - 3MB) | Clinical pharmacology (PDF - 5MB) | Statistical (PDF 185KB) | BPCA |
| 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 |
| Tenofovir disoproxil fumarate - Viread | Gilead Sciences | Medical (PDF -2.4MB) | Clinical pharmacology (PDF -1.4MB) | Statistical (PDF -1.4MB) | PREA |
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