New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration

United Therapeutics Corporation and its wholly-owned subsidiary, Lung Rx, Inc., announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of an inhaled formulation of treprostinil (ITRE) for the treatment of pulmonary arterial hypertension (PAH), a chronic, life-threatening disease. The submission starts a 60-day period during which the FDA will examine the application for completeness. If the FDA accepts the ITRE NDA for review, then it is expected to be subject to the standard 10- to 12-month review period before an action letter is issued.

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