New Drug Applications: June 2006

June 1	CTI and FDA Agree on NDA Filing Strategy for Xyotax
June 2	FDA Says Tibolone Not Approvable as a Menopause Treatment in the U.S.
June 2	Bristol-Myers Squibb Issues Statement on Oncologic Drugs Advisory Committee Vote in Favor of Investigational Drug Dasatinib
June 5	FDA Grants Adeza Priority Review for Gestiva to Prevent Preterm Births
June 7	Zolinza, Merck's Investigational Medicine for Advanced Cutaneous T-Cell Lymphoma (CTCL), to Receive Priority Review from U.S. Food and Drug Administration
June 9	Pozen Inc. and GlaxoSmithKline Report Receipt of Approvable Letter for Investigational Migraine Treatment
June 12	Saforis NDA Accepted by U.S. FDA for Priority Review
June 15	FDA Grants Class 1 Review to Encysive Pharmaceuticals’ Complete Response to Thelin NDA
June 15	Neurocrine Completes Review of Indiplon Action Letters
June 19	FDA Informs Avanir of Revised Neurodex NDA Action Date
June 20	EMD Pharmaceuticals Announces Submission of New Drug Application for Cyanokit for Treatment of Cyanide Poisoning
June 26	Wyeth Submits Two New Drug Applications for Women's Health Therapies
June 26	Wyeth Submits Two NDAs for Women’s Health Therapies
June 26	Wyeth Submits Two New Drug Applications for Women's Health Therapies
June 28	Wyeth Receives Approvable Letter From the FDA for Lybrel
June 29	InSite Vision Announces Submission of AzaSite NDA
June 29	Cephalon Receives Approvable Letter for Fentora (fentanyl buccal tablet) for Management of Breakthrough Pain in Patients with Cancer
June 30	EPIX Pharmaceuticals Files Appeal with FDA Regarding Vasovist Approvable Letters
June 30	DOR BioPharma Provides Regulatory Update on orBec
June 30	Hana Biosciences Submits Zensana NDA to the FDA
June 30	FDA Extends PDUFA Date for Polyphenon E Ointment to October 31, 2006

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New Drug Applications: June 2006

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