New Drug Applications Archive - February 2010
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February 2, 2010
- Protalix Announces NDA Submission Update for taliglucerase alfa for the Treatment of Gaucher Disease
- Teva Announces FDA Accepts BLA for XM02
- FDA Accepts Javelin Pharmaceuticals' Dyloject New Drug Application for Formal Review
February 4, 2010
- XenoPort Announces Horizant as Brand Name for XP13512
- Lux Biosciences Files for Luveniq Approval in US and Europe for Noninfectious Uveitis
February 8, 2010
February 9, 2010
- Chelsea Therapeutics Announces Advancements in Neurogenic Orthostatic Hypotension Registration Program
- FDA Postpones Oncologic Drugs Advisory Committee Meeting to Review Pixantrone Due to Severe Weather Conditions
- Extreme Weather in Washington D.C. has Postponed the FDA's Oncologic Drugs Advisory Committee Meeting Scheduled for 10 February 2010
February 10, 2010
- Biovail Enters into License and Collaboration Agreement with Alexza for AZ-004
- XenoPort Announces Extension of the Horizant PDUFA Date to February 11, 2010
February 11, 2010
- Cadence Pharmaceuticals Receives Complete Response Letter from FDA for Intravenous Acetaminophen NDA
February 17, 2010
- CombinatoRx Announces Extension of Exalgo Extended-Release Tablets PDUFA Date to March 1, 2010
- Javelin Pharmaceuticals' Receives FDA PDUFA Date for Dyloject NDA
February 18, 2010
- GlaxoSmithKline and XenoPort Receive FDA Complete Response Letter for Horizant (GSK1838262/XP13512) for RLS
- Alexza Announces AZ-004 (Staccato Loxapine) PDUFA Goal Date of October 11, 2010
February 19, 2010
- Jazz Pharmaceuticals Announces FDA Acceptance of its New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia
- Depomed Comments on DM-1796 Pre-NDA Meeting and Horizant Complete Response Letter
