New and Generic Drug Approvals April 28, 2011

Drugs@FDA Download File (updated)
Drug Firm Annual Registration Status (updated)
FDA approves Zytiga for late-stage prostate cancer
Generic Drug User Fee; Public Meeting; Request for Comments; May 10, 2011, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 1, Conference Rooms 4101, 4103, and 4105, Silver Spring, MD 20993-0002. Meeting information
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
Natural Disaster Response (updated)
Prescription Drug User Fee Act (PDUFA) Meetings:
FDA-Stakeholder Meeting Minutes, March 18, 2011 (PDF - 71KB)
FDA-Stakeholder Meeting Minutes, February 28, 2011 (PDF - 76KB)
FDA-Industry Meeting Minutes, March 31, 2011 (PDF - 69KB)
FDA-Industry Meeting Minutes, March 25, 2011 (PDF - 62KB)
FDA-Industry Meeting Minutes, March 15, 2011 (PDF - 62KB)
FDA-Industry Meeting Minutes, March 10, 2011 (PDF - 63KB)
FDA-Industry Meeting Minutes, February 24, 2011 (PDF - 70KB)
FDA-Industry Meeting Minutes, February 15, 2011 (PDF - 66KB)
FDA-Industry Meeting Minutes, February 10, 2011 (PDF - 80KB)




Pediatric Advil (ibuprofen) Oral Suspension, Pfizer Consumer Healthcare, Labeling Revision
Advil (ibuprofen) Tablets, Pfizer Consumer Healthcare, Labeling Revision
Desloratadine and Pseudoephedrine Sulfate Extended-Release Tablets, Reddy's Laboratories Ltd., Approval
Duexis (ibuprofen and famotidine) Tablets, Horizon Pharma, Inc., Approval
Lyrica (pregabalin) Capsules, Pfizer, Inc., Labeling Revision
Lyrica (pregabalin) Oral Solution, Pfizer, Inc., Labeling Revision
Naratriptan Tablets, Apotex Corp., Approval
Premarin (conjugated estrogens) Vaginal Cream, Pfizer Inc., Labeling Revision
Savella (milnacipran hydrochloride) Tablets, Forest Laboratories, Inc., Supplement
Zytiga (abiraterone acetate) Tablets, Centocor Ortho Biotech, Inc, Approval