FDA Acknowledges NDA Resubmission for Treprostinil for PAH

United Therapeutics Corp. announced that the 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 (PAH). Treprostinil, a prostacyclin vasodilator, causes direct vasodilation of pulmonary and systemic arterial vascular beds, and inhibition of platelet aggregation.

The FDA classified the resubmission as a complete class 1 response to the FDA's October 23, 2013 Complete Response Letter (CRL) and the FDA set a user fee goal date of March 31, 2013.

For more information call (301) 608-9292 or visit www.unither.com