HOUSTON, June 15 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals (Nasdaq: ENCY - News) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's complete response to the March 24 approvable letter regarding its New Drug Application (NDA) for Thelin(TM) (sitaxsentan sodium) 100 mg tablets. The FDA has designated the review as a Class 1 resubmission and issued a new Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2006 for the Thelin NDA.
Thelin is currently being evaluated by the FDA as a potential new oral treatment for patients with pulmonary arterial hypertension.
Encysive recently received a positive opinion recommending the approval of Thelin 100 mg tablets by the Committee for Medicinal Products for Human Use (CHMP) of the European Agency for the Evaluation of Medicinal Products (EMEA). A final decision for European approval is expected within 90 days of the CHMP positive opinion.
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 .
This press release contains "forward-looking statements" 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 and other regulatory authorities regarding whether and when to approve our drug applications 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.
Source: Encysive Pharmaceuticals Inc.