New Drug Applications Archive - September 2007
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September 4, 2007
- Merck Applies to Extend Use of Erbitux for 1st-Line Colorectal Cancer
- Sciele Pharma Announces Acceptance by FDA of sNDA for New Sular Formulation
September 6, 2007
- Encysive Pharmaceuticals Receives Written Response From FDA On Its Request for Formal Dispute Resolution for Thelin (Sitaxsentan Sodium)
- FDA Advisory Committee Unanimously Recommends Accelerated Approval of Isentress (raltegravir), Merck's Investigational Oral Integrase Inhibitor, for Treatment of HIV
September 10, 2007
September 13, 2007
September 14, 2007
September 17, 2007
September 20, 2007
September 21, 2007
September 24, 2007
- FDA Accepts sNDA for Expanded Use of Angiomax (bivalirudin)
- Nitec's IND Application for Clinical Development With LodotraAccepted by the FDA
- NexMed Files NDA for Proprietary Erectile Dysfunction Treatment
September 25, 2007
- Alcon Receives FDA Decision on Retaane Suspension for Wet AMD
- Labopharm Provides Update on U.S. Regulatory Process for Once-Daily Tramadol
September 26, 2007
September 27, 2007
- MGI Pharma Announces Submission of Aquavan NDA
- Prexige Receives "Not Approvable" Letter in the US Despite Being One of the Most Studied COX-2 Inhibitors
- Vanda Pharmaceuticals Submits Iloperidone New Drug Application
