New Drug Applications Archive - August 2007
Get news by email or subscribe to our news feeds.
August 1, 2007
- Joint FDA Advisory Committee Recommends Approval of Tysabri for the Treatment of Moderate to Severe Crohn's Disease
- Par Pharmaceutical Licenses North American Rights to Zensana from Hana Biosciences
August 2, 2007
- FDA Issues Second Approvable Letter for Trexima
- Discovery Labs Provides Update On Progress for Surfaxin for RDS
August 3, 2007
August 6, 2007
August 7, 2007
- The Medicines Company Submits Angiomax (Bivalirudin) sNDA to Expand Label to Include Acuity Data
- Orenica (abatacept) Supplemental Biologics License Application for Juvenile Idiopathic Arthritis Accepted by FDA for Filing and Review
- Encysive Pharmaceuticals Files Request for Formal Dispute Resolution With U.S. FDA to Contest Third Approvable Letter for Thelin
August 8, 2007
- Rilonacept (IL-1 Trap) Granted FDA Priority Review for the Treatment of CAPS
- GSK Receives Decision From FDA on Advair 500/50 for COPD
August 10, 2007
August 14, 2007
August 15, 2007
August 16, 2007
August 17, 2007
- Indevus Receives Approvable Letter From FDA for Valstar for Bladder Cancer Therapy
- UCB Announces Submission of Lacosamide Marketing Application for Diabetic Neuropathic Pain
- Endo and Vernalis Provide Update on Frova
August 20, 2007
- Nexavar Granted FDA Priority Review for Treatment of Liver Cancer
- Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
- Solvay Pharmaceuticals, Inc. Receives Approvable Letter from FDA with Respect to New Drug Application for Creon
August 21, 2007
August 22, 2007
- Neurocrine Announces PDUFA Action Date of December 12, 2007 for Indiplon Capsules
- FDA Advisory Panel to Review Medtronic's Endeavor Drug Eluting Stent in October
August 24, 2007
August 27, 2007
August 28, 2007
- Indevus Announces Submission of New Drug Application for Nebido
- Schering-Plough/Merck Pharmaceuticals Announce FDA FilingAcceptance of New Drug Application for Loratadine/MontelukastTablet
- FDA Accepts for Review Complete Response to Approvable Letter for Entereg (alvimopan) for POI
- Neurochem Provides Information on Cash Position
