New Drug Applications Archive - January 2008
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January 2, 2008
- Cephalon Submits New Drug Application for Treanda for the Treatment of Patients with Relapsed Indolent Non-Hodgkin's Lymphoma
- Forest and Cypress Announce Submission of New Drug Application for Milnacipran for the Treatment of Fibromyalgia Syndrome
- Theravance Receives Notice of Possible Telavancin Review by FDA Advisory Committee
January 3, 2008
January 4, 2008
- Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S.
- TAP Pharmaceutical Products Inc. Files New Drug Application for TAK-390MR in Patients with Acid-Related Disorders
- Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Administration
January 8, 2008
January 9, 2008
January 10, 2008
- Progenics and Wyeth Announce NDA Review Period for Subcutaneous Methylnaltrexone Extended by Three Months
- FDA Accepts for Filing the BEMA Fentanyl NDA from BioDelivery Sciences
- Basilea Announces Review of Ceftobiprole NDA at FDA Anti-Infective Drugs Advisory Committee Meeting
January 14, 2008
- FDA Extends Review of Genasense NDA Appeal in Chronic Lymphocytic Leukemia
- Inspire Announces Its Termination of Bilastine Licensing Agreement
January 16, 2008
- Ligand Partner Pfizer Submits NDA for Fablyn
- Pozen Submits Human Lymphocyte Study for Treximet (Formerly Known as Trexima)
January 18, 2008
January 22, 2008
- Cardiome And Astellas Announce Kynapid Regulatory Update
- Hologic Announces Sale of Gestiva
- Xanthus Announces Oral Fludarabine NDA Accepted for Review by U.S. FDA
January 23, 2008
January 24, 2008
- Adolor and GlaxoSmithKline Report Favorable FDA Advisory Committee Meeting for Entereg (alvimopan) for the Management of Postoperative Ileus in Bowel Resection
- New Drug Application Submitted to FDA for Investigational Analgesic Tapentadol Immediate Release Tablets
- Labopharm Receives FDA Response to Recent Appeal of Approvable Letter For Once-Daily Tramadol
January 29, 2008
- Pipex Pharmaceuticals Provides Update on Coprexa (Oral Tetrathiomolybdate) New Drug Application
- Pharming Provides Update on Rhucin
