Thelin
Generic name: sitaxsentan
Treatment for: Pulmonary Arterial Hypertension (PAH)
Encysive Pharmaceuticals Submits Response to FDA For Thelin New Drug Application
HOUSTON, December 14, 2006 -- Encysive Pharmaceuticals today announced it has provided the information requested by the U.S. Food and Drug Administration (FDA) in its letter to the Company dated December 13, 2006 regarding the Company's New Drug Application (NDA) for Thelin (sitaxsentan sodium) 100 mg tablets. This submission is Encysive's response to the FDA's determination that the Company's November 2, 2006 submission was not complete. The FDA is currently evaluating Thelin as a potential new oral treatment for pulmonary arterial hypertension.
If the FDA agrees that today's submission, taken together with the Company's November 2, 2006 submission, represents a complete response, the FDA will establish a new Prescription Drug User Fee Act (PDUFA) action date.
Posted: December 2006
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Thelin (sitaxsentan) FDA Approval History
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