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New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

May 2005

May 2 BDSI Announces Submission of NDA for Emezine; First Transmucosal Product for the Treatment of Nausea and Vomiting
May 2 Merck Submits Biologics License Application to FDA for Zostavax, an Investigational Vaccine for Shingles and Shingles-Associated Nerve Pain
May 2 FDA Accepts Tercica's Increlex New Drug Application With Priority Review for the Treatment of Short Stature
May 3 InKine Announces Submission of a New Drug Application -NDA- for Its Next Generation Purgative Product - INKP-102
May 3 Novartis Files Exjade New Drug Applications for Treatment of Chronic Iron Overload Due to Blood Transfusions
May 5 Cellegy Reports New FDA Target Response Date of June 15
May 8 Teva Receives Follow-up Approvable Letter from FDA Regarding Agilect
May 11 Vicuron Pharmaceuticals Announces Extension of FDA Review of Dalbavancin New Drug Application
May 11 Further Trial Data Awaited for Bonefos in the U.S.
May 19 FDA Antiviral Drugs Advisory Committee Recommends Accelerated Approval for Investigational Anti-HIV Drug Tipranavir
May 23 EPIX Submits Response to FDA Approvable Letter
May 24 Alcon Receives Approvable Letter from FDA for Retaane Suspension
May 25 Encysive Pharmaceuticals Submits New Drug Application for Thelin
May 25 Barrier Therapeutics Receives Not Approvable Letter From the FDA for Zimycan
May 25 GlaxoSmithKline Submits Biologics License Application for FDA Approval of Fluarix
May 26 Neurocrine Announces Submission of New Drug Application for Indiplon Tablets
May 26 Halozyme Therapeutics Announces FDA Acceptance of Hylenex NDA
May 27 Alkermes Announces Priority Review Granted For Vivitrex (Naltrexone Long-Acting Injection) NDA Submission
May 27 Santarus Submits New Drug Application for Zegerid Chewable Tablets
May 27 Biovail Receives Tentative Approval From FDA for Zolpidem ODT for Sleep Disorders
May 31 Vicuron Pharmaceuticals Files Amendment to Anidulafungin New Drug Application (NDA) for Treatment of Esophageal Candidiasis

New Drug Applications Archive

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