What is new in FDA

May 2, 2011

FDA/DDMAC Issue Warning Letter to Three Rivers Pharmaceuticals for Infergen
Acronyms and Abbreviations File Download (updated)
Drug Shortages: Current Drug Shortages: Fentanyl Transdermal System (updated)
Drug Shortages: Current Drug Shortages: Methylphenidate HCl (updated)
Drug Shortages: Current Drug Shortages: Norepinephrine Bitartrate Injection (updated)
Drug Shortages: Current Drug Shortages: Sodium phosphate injection (updated)
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
National Drug Code Directory Search (updated)
National Drug Code Directory Download (updated)
New and Generic Drug Approvals

May 02, 2011

AndroGel (testosterone) Gel, Abbott Products, Inc., Approval
Aplenzin (bupropion hydrobromide) Extended-Release Tablets, Valeant Pharmaceuticals, Labeling Revision
Celecoxib Capsules, Mylan Pharmaceuticals, Inc., Tentative Approval
Donepezil Hydrochloride Tablets, Matrix Laboratories Limited, Tentative Approval
Fusilev (levoleucovorin calcium) I.V. Powder, Spectrum Pharmaceuticals, Inc., Efficacy Supplement
Gemcitabine Injection, Bedford Laboratories, Tentative Approval
Kytril (granisetron hydrochloride) Injection, Hoffmann-La Roche Inc., Efficacy Supplement
Lariam (mefloquine hydrochloride) Tablets, Hoffmann-La Roche Inc., Supplement
NegGram (nalidixic acid) Caplets, Sanofi-aventis U.S. Inc., Labeling Revision
Nexium I.V. (esomeprazole sodium) Intravenous Injection, AstraZeneca LP, Efficacy Supplement