NDA Accepted for Oral Treprostinil for Pulmonary Arterial Hypertension
United Therapeutics Corp. announced that the FDA has accepted for review its new drug application (NDA) for treprostinil diethanolamine sustained release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension.
Treprostinil, a prostacyclin vasodilator, is available as a solution for IV or SC injection under the brand name Remodulin and as a solution for oral inhalation under the brand name Tyvaso. The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds, and inhibition of platelet aggregation.
For more information, call (301) 608-9292 or visit www.unither.com.