United Therapeutics Corp Announces FDA Acceptance For Resubmission Of Oral Treprostinil NDA


Thursday, 14 Feb 2013 06:00am EST 

United Therapeutics Corp announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the new drug application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) 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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