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 = 8
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.	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 -606 KB)	None	Statistical (PDF -211KB)	PREA
Fluticasone propionate Lotion - Cutivate	Fougera Pharmaceuticals Inc.	Medical (PDF -3MB)	Clinical pharmacology (PDF -1MB)	Statistical (PDF -317MB)	PREA
Iron Sucrose Injection, USP - Venofer	Luitpold Pharmaceuticals, Inc.	Medical (PDF -2MB)	Clinical pharmacology (PDF -114KB)	Statistical (PDF -376KB)	PREA
Methylphenidate hydrochloride - Quillivant XR	NextWave Pharmaceuticals, Inc.	Medical (PDF -26KB)	Clinical pharmacology (PDF -588KB)	Statistical (PDF -380KB)	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 -5.9MB)	Statistical (PDF -1.2MB)	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
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)