Last March 24, Encysive Pharmaceuticals got an approvable letter form the UDFDA for its New Drug Application (NDA) for Thelin™ (sitaxsentan sodium) 100 mg tablets that is currently being evaluated as a potential new oral treatment for patients with pulmonary arterial hypertension.
Now, the USFDA has accepted for review the company’s complete response to the approvable letter for which the FDA designated as a Class 1 resubmission and issued a new Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2006 for the Thelin NDA.
In addition, Encysive also recently received a positive opinion recommending the approval of Thelin 100 mg tablets by the Committee for Medicinal Products for Human Use (CHMP) of the European Agency for the Evaluation of Medicinal Products (EMEA), whose approval is expected in 90 days.
Read more at Encysive News.
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