New Drug Applications: September 2008

September 2	Alpharma Announces Acceptance of the Embeda Capsule NDA Filing
September 2	Introgen Receives Notice Advexin U.S. BLA Not Sufficiently Complete to File
September 3	ImClone Submits Supplemental Biologics License Application for Erbitux in First-Line Head and Neck Cancer
September 3	Inhaled Treprostinil New Drug Application Filed by FDA
September 8	Ortho Biotech Files sNDA for Doxil for the Treatment of Advanced Breast Cancer
September 9	Pfizer Will Withdraw Global Marketing Applications for Dalbavancin to Conduct a New Trial
September 15	Pro-Pharmaceuticals Submits Data to FDA for Davanat NDA to Treat Advanced Colorectal Cancer
September 15	Lundbeck Submits New Drug Application (NDA) for Serdolect in the US for the Treatment of Schizophrenia
September 15	Cephalon Receives Complete Response Letter Regarding Request for Expanded Fentora Label for Non-Cancer Breakthrough Pain
September 15	FDA accepts for review the Complete Response to ceftobiprole NDA Approvable Letter
September 16	GSK and XenoPort Announce Submission of NDA Requesting FDA Approval of Solzira for Restless Legs Syndrome
September 17	Gilead Receives Complete Response Letter from U.S. Food and Drug Administration for Aztreonam Lysine for Inhalation, an Investigational Treatment for Cystic Fibrosis
September 17	Daiichi Sankyo, Inc. Files Supplemental New Drug Application for Azor as Initial Therapy for High Blood Pressure
September 18	FDA Issues Complete Response Letter to Roche for Acterma (tocilizumab) Biologics License Application
September 19	NovaDel Pharma Announces PDUFA Deadline Extension on Zolpimist
September 22	Labopharm Submits New Drug Application to FDA for DDS-04A to Treat Major Depression
September 23	FDA Accepts New Drug Application for Bucindolol, A Genetically-Targeted Treatment for Heart Failure From ARCA biopharma
September 23	Genzyme Announces FDA Priority Review for Mozobil New Drug Application
September 24	Dyax Announces Completion of Biologics License Application for DX-88 for Hereditary Angioedema
September 24	Takeda Submits a New Drug Application in the U.S. for Alogliptin (SYR-322) / Actos (pioglitazone HCl) for the Treatment of Type 2 Diabetes
September 24	Discovery Labs Reports Technical Achievements Towards Gaining FDA Approval of Surfaxin
September 26	Indevus and FDA Agree on Path Forward for Nebido
September 29	FDA Continues to Review Prasugrel New Drug Application

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New Drug Applications: September 2008

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