ThelinTreatment for Pulmonary Arterial Hypertension (PAH)
Encysive Pharmaceuticals Submits Complete Response to FDA for Thelin New Drug Application
HOUSTON, May 25, 2006 -- Encysive Pharmaceuticals today announced the submission of a complete response to the concerns and observations as noted in the March 24 approvable letter issued by the U.S. Food and Drug Administration (FDA) regarding the Company's New Drug Application (NDA) for Thelin (sitaxsentan sodium) 100 mg. The FDA is currently evaluating Thelin as a potential new oral treatment for pulmonary arterial hypertension.
"Encysive and the FDA have come to the mutual agreement that the Company's approach to responding to the items outlined in the approvable letter with our existing data set is reasonable, making possible the submission of a complete response," said Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals. "We look forward to continuing our productive relationship with the Agency."
The Company expects to hear within 30 days whether the FDA accepts the submission for review.
Posted: May 2006
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- FDA Accepts Encysive’s Complete Response to Thelin New Drug Application - December 28, 2006
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- FDA Grants Class 1 Review to Encysive Pharmaceuticals’ Complete Response to Thelin NDA - June 15, 2006
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