New Drug Applications Archive - May 2009
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May 1, 2009
May 4, 2009
- AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product
- FDA Advisory Committee to Review Arzerra (Ofatumumab)
May 5, 2009
May 6, 2009
May 7, 2009
- 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, 2009
- 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, 2009
- 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, 2009
May 20, 2009
- 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, 2009
- 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, 2009
May 26, 2009
May 27, 2009
- 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
