New Drug Applications: 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 6	Biovail Receives Approval Letter From FDA For Tramadol ODT; Oral Disintegrating Tablet Version to Provide Treatment Option for Those Who Suffer from Moderate to Moderately Severe Pain
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

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New Drug Applications: May 2005

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