Home » FDA ISSUES APPROVABLE LETTER FOR ENCYSIVE'S THELIN
FDA ISSUES APPROVABLE LETTER FOR ENCYSIVE'S THELIN
Encysive Pharmaceuticals has received an approvable letter from the FDA for Thelin (sitaxsentan sodium), which is under review for the treatment of pulmonary arterial hypertension (PAH).
The letter contains concerns and observations that must be satisfied prior to achieving approval, including a request for additional clinical trial work.
KEYWORDS Drug Pipeline Alert
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