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Thelin

sitaxsentan

Treatment for Pulmonary Arterial Hypertension (PAH)

FDA Accepts Encysive’s Complete Response to Thelin New Drug Application

Conference Call Scheduled for Today at 2:15 p.m. Eastern Time

HOUSTON, December 28, 2006 -- Encysive Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's complete response to the July 24, 2006 approvable letter regarding its New Drug Application (NDA) for Thelin (sitaxsentan sodium) 100 mg tablets. The FDA has designated the review as a Class 2 resubmission and issued a new Prescription Drug User Fee Act (PDUFA) target action date of June 15, 2007.

Thelin is currently being evaluated by the FDA as a potential new oral treatment for patients with pulmonary arterial hypertension (PAH).

The Company will work with the FDA to schedule a meeting as soon as possible in an effort to clarify the situation and move the application forward.

Encysive is currently in the process of commercializing Thelin 100 mg in the European Union, following the August 2006 receipt of marketing authorization from the European Commission. To date, Thelin has been launched in the United Kingdom and Germany.

Conference Call Information

Encysive will host a conference call today at 2:15 p.m. ET. You may access the call either through the call-in number below or through the audio webcast. Please dial-in 15 minutes prior to the start time to allow for call processing. The access number for the call is:

Number: (612) 332-0107
Passcode: Encysive Pharmaceuticals

This call is being webcast and can be accessed via Encysive's web site at www.encysive.com

A replay of the webcast will be available on the Company's web site through January 26, 2007. Additionally, a replay of the call will be available until Monday, January 1, 2007 at 11:59 p.m. ET. The call replay can be accessed by calling:

Number: (320) 365-3844
Access Code: 857478

Source: Encysive Pharmaceuticals Inc.

Related Articles:

Encysive Pharmaceuticals Receives Written Response From FDA On Its Request for Formal Dispute Resolution for Thelin (Sitaxsentan Sodium) - September 6, 2007

Encysive Pharmaceuticals Files Request for Formal Dispute Resolution With U.S. FDA to Contest Third Approvable Letter for Thelin - August 7, 2007

Encysive Pharmaceuticals Provides Update for Thelin (Sitaxsentan Sodium) - July 13, 2007

FDA Issues Third Approvable Letter for Thelin (Sitaxsentan Sodium) - June 18, 2007

Encysive Pharmaceuticals Submits Response to FDA For Thelin New Drug Application - December 15, 2006

Encysive Expects to Submit Revised Response to Thelin Approvable Letter Within Several Days - December 14, 2006

Encysive Submits Complete Response to FDA For Thelin New Drug Application - November 2, 2006

FDA Issues Approvable Letter for Thelin; One Outstanding Item Remains - July 24, 2006

FDA Grants Class 1 Review to Encysive Pharmaceuticals’ Complete Response to Thelin NDA - June 15, 2006