What's New on the FDA Drugs Site

May 26, 2011

Drug Shortages: Current Drug Shortages: Methylphenidate HCl (updated)
Drug Shortages: Current Drug Shortages: Norepinephrine Bitartrate Injection (updated)
ANDA Checklist for Completeness and Acceptability (PDF - 159KB) (updated)
CDER Key Officials List (PDF - 114KB) (Updated)
Drug Firm Annual Registration Status (updated)
Drugs@FDA Download File (updated)
FDA Statement on the AIM-HIGH Trial
FDA/DDMAC Issue Letter to Noven Pharmaceuticals for Pexeva (PDF - 45KB)
Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals

May 26, 2011

Lamivudine and Zidovudine Tablets, TEVA Pharmaceuticals, Approval
Risperidone Oral Solution, Amneal Pharmaceuticals, Approval
Tenofovir Disoproxil Fumarate Tablets, Strides Inc., Tentative Approval
Warfarin Sodium Tablets, Invagen Pharmaceuticals, Inc., Approval