What's New on the FDA Drugs Site

May 16, 2011

CDER Forum for International Drug Regulatory Authorities, October 17-21, 2011, College Park, MD. Meeting information
Drug Firm Annual Registration Status (updated)
National Drug Code Directory Search (updated)
National Drug Code Directory Download (updated)
Prescription Drug User Fee Act (PDUFA) Meetings:
FDA-Industry Meeting Minutes, February 24, 2011 (PDF - 66KB)
FDA-Industry Meeting Minutes, February 10, 2011 (PDF - 65KB)
FDA-Industry Meeting Minutes, January 31, 2011 (PDF - 64KB)
New and Generic Drug Approvals

May 16, 2011

Epzicom (abacavir sulfate and lamivudine) Tablets, GlaxoSmithKline, Labeling Revision
Irinotecan Hydrochloride Injection, Bioniche Pharma USA LLC., Approval
Janumet (sitagliptin phosphate and metformin hydrochloride) Tablets, Merck Sharp and Dohme Corp., Labeling Revision
Levocetirizine Dihydrochloride Oral Solution, Synthon Pharmaceuticals, Inc., Tentative Approval
Mirapex (pramipexole dihydrochloride) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Efficacy Supplement
Sodium Polystyrene Sulfonate Suspension, Paddock Laboratories, Inc., Approval
Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets, GlaxoSmithKline, Labeling Revision
Ziagen (abacavir sulfate) Tablets, GlaxoSmithKline, Labeling Revision
Ziagen (abacavir sulfate) Oral Solution, GlaxoSmithKline, Labeling Revision