What's New on the FDA Drugs Site

June 7, 2011

BPCA/Pediatric Exclusivity Statistics
Pediatric Exclusivity Granted (updated)
Pediatric Exclusivity Statistics (updated)
Drug Firm Annual Registration Status (updated)
Drug Shortages: Current Drug Shortages: Magnesium Sulfate Injection
Drug Shortages: Current Drug Shortages: Methylphenidate HCl (updated)
MedWatch Safety Alert: American Regent Injectable Products: Recall - Visible Particulates in Products (updated)
National Drug Code Directory (updated)
NDC Product File Definitions (updated)
NDC Package File Definitions (updated)
June 6, 2011

Guidance for Industry: Enforcement of Safety Reporting Requirements for INDs and BA/BE Studies (PDF - 41KB)
New and Generic Drug Approvals

June 7, 2011

Avalide (hydrochlorothiazide and irbesartan) Tablets, Sanofi-Aventis, Labeling Revision
Benicar (olmesartan medoxomil) Tablets, Daiichi Sankyo Inc., Labeling Revision
Corgard (nadolol) Tablets, King Pharmaceuticals Inc., Labeling Revision
Corzide (bendroflumethiazide and nadolol) Tablets, Pfizer, Inc., Labeling Revision
Diflucan in Dextrose 5% in Plastic Container (fluconazole) Injection, Pfizer, Inc., Labeling Revision
Diflucan (fluconazole) Oral Suspension, Pfizer, Inc., Labeling Revision
Diflucan (fluconazole) Tablets, Pfizer, Inc., Labeling Revision
Losartan Potassium Tablets, Huahai US Inc., Approval
Macrobid (nitrofurantoin and macrocrystaline) Capsules, Almatica Pharma, Inc., Labeling Revision
Macrodantin (nitrofurantoin macrocrystals) Capsules, Almatica Pharma, Inc., Labeling Revision
Twynsta (amlodipine besylate and telmisartan) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
Rapamune (sirolimus) Oral Solution, Wyeth Pharmaceuticals, Inc., Approval
Rapamune (sirolimus) Tablets, Wyeth Pharmaceuticals, Inc., Approval
Zolpidem Tartrate Extended-Release Tablets, Actavis South Atlantic LLC, Approval
Zolpidem Tartrate Extended-Release Tablets, Synthon Pharmaceuticals, Inc., Approval
June 6, 2011

Diovan (valsartan) Tablets, Novartis, Labeling Revision
Letrozole Tablets, Synthon Pharmaceuticals, Inc., Approval
Letrozole Tablets, Fresenius Kabi Oncology, Approval
Letrozole Tablets, Endo Pharmaceuticals, Inc., Approval
Letrozole Tablets, Dr. Reddy’s Laboratories Ltd., Approval
Letrozole Tablets, Roxane Laboratories, Inc., Approval
Letrozole Tablets, Natco Pharma Ltd., Approval
Letrozole Tablets, Accord Healthcare, Inc., Approval
Letrozole Tablets, Impax Laboratories, Inc., Approval
Letrozole Tablets, Sun Pharmaceutical Industries Ltd., Approval
Letrozole Tablets, Kudco Ireland Ltd., Approval
Letrozole Tablets, TEVA Pharmaceuticals, Approval