New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

May 2009

May 1

Northfield Receives Complete Response Letter for PolyHeme BLA

May 4

AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product 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 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 Discovery Labs and FDA to Meet On June 2, 2009 to Discuss Surfaxin Complete Response Letter AMAG Pharmaceuticals Announces New PDUFA Date for Feraheme (ferumoxytol injection)

May 13

Pozen Receives Decision from AstraZeneca to File PN 400 NDA 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 Lundbeck provides update on NDA for Serdolect for the treatment of schizophrenia

May 21

Emisphere Technologies Receives Milestone Payment from MannKind Corporation Human Genome Sciences Submits Biologics License Application to FDA for ABthrax 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 FDA Extends Review Timeline for Stelara (ustekinumab) Biologic License Application by Three Months 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 Advanced Life Sciences Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Restanza (cethromycin)

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