Thelin
sitaxsentan
Treatment for Pulmonary Arterial Hypertension (PAH)Encysive Expects to Submit Revised Response to Thelin Approvable Letter Within Several Days
Conference Call Scheduled for Today At 9:00 a.m. Eastern
Houston, TX – December 14, 2006 – Encysive Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration (FDA) informed the Company that its response to the July 24, 2006 approvable letter for Thelin (sitaxsentan sodium) 100 mg tablets is not considered to be complete. The FDA has requested that the Company provide information in a certain tabular format. The Company expects to provide the requested information within several days, and is hopeful that this information will resolve any remaining questions. Based on the straight-forward nature of the request, Encysive will ask the FDA to review the new tables expeditiously.
Conference Call Information
Encysive Pharmaceuticals will host a conference call today at 9:00 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) 288-0340 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 15, 2007. Additionally, a replay of the call will be available from Thursday, December 14, 2006, at 11:30 a.m. ET until Monday, December 18, 2006, at 11:59 p.m. ET. The call replay can be accessed by calling:
Number: (320) 365-3844 Access Code: 853968
Source: Encysive Pharmaceuticals Inc.
Related Articles:
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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
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 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
Encysive Pharmaceuticals Submits Complete Response to FDA for Thelin New Drug Application - May 25, 2006
Encysive Pharmaceuticals Receives Approvable Letter From FDA for Thelin - March 24, 2006
Encysive Announces PDUFA Date for Thelin New Drug Application in Pulmonary Arterial Hypertension - July 14, 2005
Encysive Pharmaceuticals Submits New Drug Application for Thelin - May 25, 2005
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