New Drug Applications: January 2008

January 2	Cephalon Submits New Drug Application for Treanda for the Treatment of Patients with Relapsed Indolent Non-Hodgkin's Lymphoma
January 2	Forest and Cypress Announce Submission of New Drug Application for Milnacipran for the Treatment of Fibromyalgia Syndrome
January 2	Theravance Receives Notice of Possible Telavancin Review by FDA Advisory Committee
January 3	Schering-Plough Announces New Drug Application for Sugammadex Assigned Priority Review Status by U.S. FDA
January 4	TAP Pharmaceutical Products Inc. Files New Drug Application for TAK-390MR in Patients with Acid-Related Disorders
January 4	Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S.
January 4	Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Administration
January 8	FDA Cancels Advisory Committee Meeting for Icatibant in the Treatment of HAE - Priority Review of Jerini's NDA Continues
January 9	Hemispherx Biopharma Addresses FDA Questions On Ampligen NDA
January 10	Progenics and Wyeth Announce NDA Review Period for Subcutaneous Methylnaltrexone Extended by Three Months
January 10	FDA Accepts for Filing the BEMA Fentanyl NDA from BioDelivery Sciences
January 10	Basilea Announces Review of Ceftobiprole NDA at FDA Anti-Infective Drugs Advisory Committee Meeting
January 14	FDA Extends Review of Genasense NDA Appeal in Chronic Lymphocytic Leukemia
January 16	Ligand Partner Pfizer Submits NDA for Fablyn
January 16	Pozen Submits Human Lymphocyte Study for Treximet (Formerly Known as Trexima)
January 18	Adolor Announces Availability of Briefing Documents For January 23rd FDA Advisory Committee Meeting on Entereg (alvimopan)
January 22	Cardiome And Astellas Announce Kynapid Regulatory Update
January 22	Hologic Announces Sale of Gestiva
January 22	Xanthus Announces Oral Fludarabine NDA Accepted for Review by U.S. FDA
January 23	NovaDel's New Drug Application for ZolpiMist Oral Spray to Treat Insomnia Accepted for Filing by the U.S. Food and Drug Administration
January 24	Adolor and GlaxoSmithKline Report Favorable FDA Advisory Committee Meeting for Entereg (alvimopan) for the Management of Postoperative Ileus in Bowel Resection
January 24	New Drug Application Submitted to FDA for Investigational Analgesic Tapentadol Immediate Release Tablets
January 29	Pharming Provides Update on Rhucin
January 29	Pipex Pharmaceuticals Provides Update on Coprexa (Oral Tetrathiomolybdate) New Drug Application
January 30	IMPAX Receives FDA Non-Approvable Letter for Vadova; Company Considering Options
January 31	Ipsen: FDA Accepts for Filing a Biologics License Application (BLA) for Dysport in Cervical Dystonia
January 31	Lev Pharmaceuticals Receives Complete Response Letter for Cinryze
January 31	Somaxon Pharmaceuticals Submits New Drug Application for Silenor for the Treatment of Insomnia

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New Drug Applications: January 2008

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