Thelin
Generic name: sitaxsentan
Treatment for: Pulmonary Arterial Hypertension (PAH)
Encysive Submits Complete Response to FDA For Thelin New Drug Application
HOUSTON, November 2, 2006 -- Encysive Pharmaceuticals announced that following discussions today with the U.S. Food and Drug Administration (FDA), the Company has submitted a complete response to the July 24, 2006 approvable letter issued by the FDA regarding the Company's New Drug Application (NDA) for Thelin (sitaxsentan sodium) 100 mg tablets. The FDA is currently evaluating Thelin as a potential new oral treatment for pulmonary arterial hypertension.
The Company expects to hear within approximately 30 days whether the FDA accepts the submission and if so, the FDA will establish a new PDUFA action date.
Posted: November 2006
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Thelin (sitaxsentan) FDA Approval History
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