New Drug Applications Archive

New Drug Applications: May 2009

May 1	Northfield Receives Complete Response Letter for PolyHeme BLA
May 4	AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product
May 4	FDA Advisory Committee to Review Arzerra (Ofatumumab)
May 5	Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes
May 6	Acorda Therapeutics Announces FDA Acceptance of Fampridine-SR New Drug Application for Filing
May 7	Savient Announces New Date for FDA Arthritis Advisory Panel Review of Krystexxa for Treatment Failure Gout
May 7	Bioalliance Pharma to Resubmit Loramyc NDA in the Second Quarter of 2009
May 12	Food and Drug Administration Accepts Isolagen's Biologics License Application for Full Review
May 12	Discovery Labs and FDA to Meet On June 2, 2009 to Discuss Surfaxin Complete Response Letter
May 12	AMAG Pharmaceuticals Announces New PDUFA Date for Feraheme (ferumoxytol injection)
May 13	Pozen Receives Decision from AstraZeneca to File PN 400 NDA
May 13	Cadence Pharmaceuticals Submits Acetavance New Drug Application for the Treatment of Acute Pain and Fever
May 18	A.P. Pharma Submits New Drug Application for APF530 in Chemotherapy-Induced Nausea and Vomiting
May 20	Genentech and Biogen Idec Submit Applications to the FDA for Rituxan for Most Common Type of Adult Leukemia
May 20	Lundbeck provides update on NDA for Serdolect for the treatment of schizophrenia
May 21	Emisphere Technologies Receives Milestone Payment from MannKind Corporation
May 21	Human Genome Sciences Submits Biologics License Application to FDA for ABthrax
May 21	Genzyme Submits All Information Requested by FDA for Lumizyme
May 22	Skyepharma plc: Flutiform NDA Accepted for Review
May 26	PharmAthene Submits SparVax Regulatory Strategy to FDA
May 27	Allergan Receives Complete Response Letter for Botox (Botulinum Toxin Type A) for Treatment of Upper Limb Spasticity in Adults
May 27	FDA Extends Review Timeline for Stelara (ustekinumab) Biologic License Application by Three Months
May 27	Warner Chilcott Announces FDA Acceptance of NDA Submission for Low Dose Oral Contraceptive
May 28	U.S. FDA Issues Complete Response Letter for Rivaroxaban
May 29	GSK/Genmab Receive Favorable Recommendation for Arzerra from FDA Advisory Panel
May 29	Advanced Life Sciences Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Restanza (cethromycin)

New Drug Applications Archive

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