Encysive Pharmaceuticals Submits Response to FDA For Thelin New Drug Application
Thursday December 14, 9:03 pm ET
HOUSTON, Dec. 14, 2006 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (NASDAQ:ENCY - News) today announced it has provided the information requested by the U.S. Food and Drug Administration (FDA) in its letter to the Company dated December 13, 2006 regarding the Company's New Drug Application (NDA) for Thelin(tm) (sitaxsentan sodium) 100 mg tablets. This submission is Encysive's response to the FDA's determination that the Company's November 2, 2006 submission was not complete. The FDA is currently evaluating Thelin(tm) as a potential new oral treatment for pulmonary arterial hypertension.
If the FDA agrees that today's submission, taken together with the Company's November 2, 2006 submission, represents a complete response, the FDA will establish a new Prescription Drug User Fee Act (PDUFA) action date.
About Encysive Pharmaceuticals
Encysive Pharmaceuticals Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of novel, synthetic, small molecule compounds to address unmet medical needs. Our research and development programs are predominantly focused on the treatment and prevention of interrelated diseases of the vascular endothelium and exploit our expertise in the area of the intravascular inflammatory process, referred to as the inflammatory cascade, and vascular diseases. To learn more about Encysive Pharmaceuticals please visit our web site: encysive.com. |
