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.


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