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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.
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
Neurocrine Completes Review of Indiplon Action Letters
FDA Grants Class 1 Review to Encysive Pharmaceuticals’ Complete Response to Thelin NDA
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
Wyeth Submits Two NDAs for Women’s Health Therapies
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
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
DOR BioPharma Provides Regulatory Update on orBec
Hana Biosciences Submits Zensana NDA to the FDA
FDA Extends PDUFA Date for Polyphenon E Ointment to October 31, 2006
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