FDA Reviews Oral Treprostinil for Pulmonary Arterial Hypertension

FDA Reviews Oral Treprostinil for Pulmonary Arterial Hypertension
FDA Reviews Oral Treprostinil for Pulmonary Arterial Hypertension

United Therapeutics announced that the FDA has accepted for review its resubmission of a New Drug Application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension. Treprostinil, a prostacyclin vasodilator, causes direct vasodilation of pulmonary and systemic arterial vascular beds, and inhibition of platelet aggregation.

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The FDA classified the resubmission as a complete, class 2 response to its March 22, 2013 Complete Response Letter (CRL) and set a user fee goal date of February 16, 2014.

Treprostinil is already 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.

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