FDA to again review oral treprostinil for PAH

FDA accepted for review a resubmitted NDA from United Therapeutics Corp. (NASDAQ:UTHR) for oral treprostinil to treat pulmonary arterial hypertension (PAH). The PDUFA date is Feb. 16, 2014. In March, FDA issued a second complete response letter for the product, though the company declined to disclose the contents of the letter. United Therapeutics already markets IV and subcutaneous formulations of the synthetic long-acting stable prostacyclin analog as Remodulin in the U.S. and an inhaled formulation as Tyvaso (see BioCentury, March 25). ...