Encysive sumbits response to Thelin approvable letter
The USA's Encysive Pharmaceuticals has provided information requested by the Food and Drug Administration in its letter to the company dated December 13, regarding the New Drug Application for Thelin (sitaxsentan sodium) 100mg tablets.
The submission is Encysive's response to the FDA's determination that its November 2, submission was not complete. The FDA is currently evaluating the agent as a potential new oral treatment for pulmonary arterial hypertension. If the Agency agrees that the new submission represents a complete response, it will establish a new action date.
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