Encysive Pharmaceuticals Submits Response to FDA For Thelin New Drug Application
Posted on: Thursday, 14 December 2006, 21:00 CST
HOUSTON, Dec. 14, 2006 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (Nasdaq:ENCY) 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: http://www.encysive.com.
The Encysive Pharmaceuticals Inc. logo is available at http://media.primezone.com/prs/single/?pkgid=843
This press release contains "forward-looking statement" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Among those risks, trends and uncertainties are decisions by the U.S. Food and Drug Administration regarding whether and when to approve our drug application for Thelin(tm) (sitaxsentan sodium), as well as more specific risks, trends and uncertainties facing Encysive such as those set forth in its reports on Forms 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks, trends and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore you should not rely on any such forward-looking statements. Furthermore, Encysive undertakes no duty to update or revise these forward-looking statements. The Private Securities Litigation Reform Act of 1995 permits this discussion.
This news release was distributed by PrimeNewswire, www.primenewswire.com
CONTACT: Encysive Pharmaceuticals Ann Tanabe VP, Investor Relations and Corporate Communications (713) 796-8822 The Trout Group Marcy Strickler (646) 378-2927 Media: BMC Communications Dan Budwick (212) 477-9007 ext. 14
Source: PrimeNewswire
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