New Drug Applications Archive - September 2008
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September 2, 2008
- Alpharma Announces Acceptance of the Embeda Capsule NDA Filing
- Introgen Receives Notice Advexin U.S. BLA Not Sufficiently Complete to File
September 3, 2008
- ImClone Submits Supplemental Biologics License Application for Erbitux in First-Line Head and Neck Cancer
- Inhaled Treprostinil New Drug Application Filed by FDA
September 8, 2008
September 9, 2008
September 10, 2008
September 15, 2008
- Pro-Pharmaceuticals Submits Data to FDA for Davanat NDA to Treat Advanced Colorectal Cancer
- Lundbeck Submits New Drug Application (NDA) for Serdolect in the US for the Treatment of Schizophrenia
- Cephalon Receives Complete Response Letter Regarding Request for Expanded Fentora Label for Non-Cancer Breakthrough Pain
- FDA accepts for review the Complete Response to ceftobiprole NDA Approvable Letter
September 16, 2008
September 17, 2008
- Daiichi Sankyo, Inc. Files Supplemental New Drug Application for Azor as Initial Therapy for High Blood Pressure
- Gilead Receives Complete Response Letter from U.S. Food and Drug Administration for Aztreonam Lysine for Inhalation, an Investigational Treatment for Cystic Fibrosis
September 18, 2008
- FDA Issues Complete Response Letter to Roche for Acterma (tocilizumab) Biologics License Application
September 19, 2008
September 22, 2008
September 23, 2008
- FDA Accepts New Drug Application for Bucindolol, A Genetically-Targeted Treatment for Heart Failure From ARCA biopharma
- Genzyme Announces FDA Priority Review for Mozobil New Drug Application
September 24, 2008
- Takeda Submits a New Drug Application in the U.S. for Alogliptin (SYR-322) / Actos (pioglitazone HCl) for the Treatment of Type 2 Diabetes
- Dyax Announces Completion of Biologics License Application for DX-88 for Hereditary Angioedema
- Discovery Labs Reports Technical Achievements Towards Gaining FDA Approval of Surfaxin
