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United Therapeutics Corporation Withdraws European Marketing Authorization Application for Tyvaso for the Treatment of Pulmonary Arterial Hypertension
Date:2/19/2010

SILVER SPRING, Md., Feb. 19 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that it has withdrawn its Marketing Authorization Application (MAA) for Tyvaso (treprostinil sodium) 0.6 mg/ml nebuliser solution for the treatment of pulmonary arterial hypertension (PAH) in the European Union.

United Therapeutics submitted its MAA for Tyvaso to the European Medicines Agency (EMA) in December 2008.  The data included in the MAA is based upon clinical work performed from 2005 to 2007 by United Therapeutics' wholly-owned subsidiary Lung Rx, LLC.  The MAA was withdrawn following communication from the Committee for Medicinal Products for Human Use (CHMP) of the EMA citing a major objection.  The major objection noted that findings of non-compliance with good clinical practices (GCP) at two
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