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February 14, 2013
06:09 EDTUTHRUnited Therapeutics reports FDA acceptance of oral Treprostinil NDA reacceptance
United Therapeutics announced that the U.S. Food and Drug Administration has acknowledged the resubmission of the new drug application for treprostinil diolamine extended release tablets for the treatment of pulmonary arterial hypertension. The FDA classified the resubmission as a complete, class 1 response to FDA's October 23, 2012 complete response letter and the FDA set a user fee goal date of March 31, 2013.
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