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news.United Therapeutics and its wholly owned subsidiary, Lung Rx, have submitted a new drug application to the FDA for marketing approval of an inhaled formulation of treprostinil for the treatment of pulmonary arterial hypertension, a chronic, life-threatening disease.
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The submission starts a 60-day period during which the FDA will examine the application for completeness. If the FDA accepts the inhaled formulation of treprostinil new drug application (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.
Martine Rothblatt, United Therapeutics’s chairman and CEO, said: “The completion of the NDA filing is a huge milestone in United Therapeutics’s quest to develop as many formulations of treprostinil as possible to create better, more convenient therapies to treat the debilitating effects of pulmonary arterial hypertension along the full spectrum of the disease.”