What is new in FDA

June 8, 2011

Drug Firm Annual Registration Status (updated)
Drug Shortages: Current Drug Shortages: Amino Acid Injection (updated)
Drugs@FDA Download File (updated)
FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury
Guidance for Industry: Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (PDF - 115KB)
New and Generic Drug Approvals

June 8, 2011

Alprazolam Extended-Release Tablets, Aurobindo Pharma Ltd., Approval
Cleocin Hydrochloride (clindamycin hydrochloride) Capsules, Pfizer, Inc., Labeling Revision
Cleocin Phosphate (clindamycin phosphate) Injection, Pfizer, Inc., Labeling Revision
Cleocin Phosphate in Dextrose 5% in Plastc Container (clindamycin phosphate) Injection, Pfizer, Inc., Labeling Revision
Clobetaso Propionate Shampoo, Actavis Mid Atlantic LLC, Approval
Dilacor XR (diltiazem hydrochloride) Extended Release Capsules, Watson Laboratories, Inc., Labeling Revision
Isosorbide Mononitrate Extended-Release Tablets, Torrent Pharmaceuticals Ltd., Approval
Letrozole Tablets, Indicus Pharma LLC., Approval
Protonix IV (pantoprazole sodium) I.V. Injection, Wyeth Pharmaceuticals Inc., Labeling Revision
Rapamune (sirolimus) Oral Solution, Wyeth Pharmaceuticals, Inc., Labeling Revision
Rapamune (sirolimus) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
Salonpas (menthol and methyl salicylate) Patch, Hisamitu Pharmaceutical Co., Inc., Labeling Revision
Temodar (temozolomide) Capsules, Schering Corporation, Labeling Revision
Temodar (temozolomide) Injection, Schering Corp., Labeling Revision