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May 2006
May 1
Cephalon Receives Approvable Letter for Nuvigil
May 4
Adeza Submits New Drug Application For Gestiva to Prevent Preterm Births
May 9
Pharmacyclics to Submit New Drug Application for Xcytrin for Treatment of Lung Cancer Patients With Brain Metastases
Hana Biosciences Reaffirms Expected Timing of First NDA Filing
May 16
Neurocrine Receives Approvable Letter for indiplon Capsules and Non-Approvable for indiplon Tablets for the Treatment of Insomnia
May 17
Shire Provides Update on U.S. Marketing Application of Elaprase
May 18
FDA Advisory Committee Votes Unanimously That Clinical Data Support the Efficacy and Safety of Gardasil
May 25
Encysive Pharmaceuticals Submits Complete Response to FDA for Thelin New Drug Application
May 26
FDA Accepts Submission for NitroMist as Complete Response
May 31
Cardiome Announces Refusal to File Decision By the FDA
Adolor’s Complete Response to Approvable Letter Accepted for Review by FDA
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