Encysive receives approvable letter from FDA for Thelin

New York, March 24 - Encysive Pharmaceuticals Inc. said it received an approvable letter from the Food and Drug Administration for Thelin (sitaxsentan sodium), which is under review for the treatment of pulmonary arterial hypertension.

The letter raises concerns and observations that must be satisfied before approval, including a request for additional clinical trial work.

"We will work in close collaboration with the FDA to clarify the path forward," said Bruce D. Given, president and chief executive officer of Encysive Pharmaceuticals, in a news release.

"We are hopeful that this can be accomplished without the need for additional clinical work, but that will require discussion with the agency before we can be sure. We remain confident in Thelin's value, and look forward to the opportunity to provide PAH [pulmonary arterial hypertension] patients with a new treatment option."

Encysive is a Houston-based biopharmaceutical company.

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