Pharmaceutical News and Articles

Thelin

sitaxsentan

Treatment for Pulmonary Arterial Hypertension (PAH)

FDA Issues Approvable Letter for Thelin; One Outstanding Item Remains

Conference Call Scheduled for Tuesday, July 25 at 8:00 a.m. ET

HOUSTON, July 24, 2006 -- Encysive Pharmaceuticals today announced that at 4:35 p.m. ET the Company received an approvable letter from the U.S. Food and Drug Administration (FDA) for Thelin (sitaxsentan sodium), which is under review for the treatment of pulmonary arterial hypertension (PAH). Of the substantive items raised in the March 24, 2006 approvable letter, one remains unresolved.

In today's approvable letter, the FDA acknowledged that the unresolved item is a matter of judgment and expressed an openness to consider new arguments to address this remaining item. The FDA again offered the alternative of conducting additional clinical work. Additionally, the FDA provided recommendations on the Company's risk management plan, which the Company views as constructive.

Conference Call Information

Encysive will host a conference call on Tuesday, July 25, 2006 at 8:00 a.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) 326-1028
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 August 24, 2006. Additionally, a replay of the call will be available until Friday, July 28, 2006 at 11:59 p.m. ET. The call replay can be accessed by calling:
Number: (320) 365-3844
Access Code: 837659

Source: Encysive Pharmaceuticals Inc.

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

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

FDA Accepts Encysive’s Complete Response to Thelin New Drug Application - December 28, 2006

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

Encysive Pharmaceuticals Submits Complete Response to FDA for Thelin New Drug Application - May 25, 2006