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Home » HYPERTENSION DRUG APPLICATION DATE ANNOUNCED
HYPERTENSION DRUG APPLICATION DATE ANNOUNCED
July 18, 2005
Encysive Pharmaceuticals announced that the FDA's Cardio-Renal Division stated that it anticipates filing Encysive's New Drug Application (NDA) for Thelin (sitaxsentan) on July 23, 2005, under a standard review classification. The FDA's Prescription Drug User Fee Act (PDUFA) target action date for Thelin is March 24, 2006.
Thelin -- a molecule that blocks the action of endothelin, a potent mediator of blood vessel constriction and growth of smooth muscle in vascular walls -- is being evaluated as a once daily oral treatment for patients with pulmonary arterial hypertension (PAH).The FDA has also requested a plan for the study of Thelin in pediatric PAH patients.
KEYWORDS Drug Pipeline Alert
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