Thelin
Generic name: 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.
Posted: December 2006
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Thelin (sitaxsentan) FDA Approval History
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