New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

September 2007

September 4

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

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

FDA Informs Endo and Vernalis That New Target Action Date on Frova sNDA Is Sept. 30, 2007

September 13

FDA Accepts ISO-Vorin New Drug Application Amendment Submitted by Spectrum Pharmaceuticals

September 14

FDA Accepts NDA Filing for Cleviprex (Clevidipine Butyrate Injectable Emulsion) for the Treatment of Acute Hypertension

September 17

FDA Accepts Sucampo's sNDA for Lubiprostone (8 mcg) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C)

September 20

FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125

September 21

Cephalon Submits New Drug Application for Treanda for the Treatment of Chronic Lymphocytic Leukemia

September 24

FDA Accepts sNDA for Expanded Use of Angiomax (bivalirudin) NexMed Files NDA for Proprietary Erectile Dysfunction Treatment Nitec's IND Application for Clinical Development With Lodotra Accepted by the FDA

September 25

Alcon Receives FDA Decision on Retaane Suspension for Wet AMD Labopharm Provides Update on U.S. Regulatory Process for Once-Daily Tramadol

September 26

Solvay Pharmaceuticals, Inc. Announces FDA Extension of Tedisamil PDUFA Date

September 27

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

September 28

CV Therapeutics Submits Supplemental New Drug Application for Ranexa (ranolazine extended-release tablets)

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