New Drug Applications: August 2007

August 1	Joint FDA Advisory Committee Recommends Approval of Tysabri for the Treatment of Moderate to Severe Crohn's Disease
August 2	FDA Issues Second Approvable Letter for Trexima
August 2	Discovery Labs Provides Update On Progress for Surfaxin for RDS
August 3	Jazz Pharmaceuticals, Inc. Announces Submission of Complete Responses to FDA Approvable Letters for Luvox CR and Luvox
August 6	SkyePharma PLC - Flutiform Progress Update
August 7	The Medicines Company Submits Angiomax (Bivalirudin) sNDA to Expand Label to Include Acuity Data
August 7	Orenica (abatacept) Supplemental Biologics License Application for Juvenile Idiopathic Arthritis Accepted by FDA for Filing and Review
August 7	Encysive Pharmaceuticals Files Request for Formal Dispute Resolution With U.S. FDA to Contest Third Approvable Letter for Thelin
August 8	Rilonacept (IL-1 Trap) Granted FDA Priority Review for the Treatment of CAPS
August 8	GSK Receives Decision From FDA on Advair 500/50 for COPD
August 10	Wyeth Pharmaceuticals and Solvay Pharmaceuticals, Inc. Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
August 14	GlaxoSmithKline's Application for Rotarix is Accepted for Review by the FDA
August 15	GlaxoSmithKline Updates Prescribing Information for Avandia
August 16	Sciele Pharma Announces FDA Acceptance of NDA for Summers Laboratories' Head Lice Treatment
August 17	Indevus Receives Approvable Letter From FDA for Valstar for Bladder Cancer Therapy
August 17	UCB Announces Submission of Lacosamide Marketing Application for Diabetic Neuropathic Pain
August 17	Endo and Vernalis Provide Update on Frova
August 20	Nexavar Granted FDA Priority Review for Treatment of Liver Cancer
August 20	Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
August 20	Solvay Pharmaceuticals, Inc. Receives Approvable Letter from FDA with Respect to New Drug Application for Creon
August 21	Daiichi Sankyo and Forest Laboratories Sign Letter of Intent for Co-Promotion of Azor
August 22	Neurocrine Announces PDUFA Action Date of December 12, 2007 for Indiplon Capsules
August 22	FDA Advisory Panel to Review Medtronic's Endeavor Drug Eluting Stent in October
August 24	Genentech Announces Resubmission of Supplemental Biologics License Application for Avastin in Combination with Paclitaxel for First-Line Metastatic Breast Cancer
August 27	IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma
August 28	Indevus Announces Submission of New Drug Application for Nebido
August 28	Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
August 28	FDA Accepts for Review Complete Response to Approvable Letter for Entereg (alvimopan) for POI
August 28	Neurochem Provides Information on Cash Position
August 29	Merck Announces FDA Acceptance of NDA for Cordaptive (ER niacin/laropiprant), Formerly Known as MK-0524A, an Investigational Lipid-Modifier
August 30	Cardiome And Astellas Announce Regulatory Extension

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New Drug Applications: August 2007

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