United Therapeutics submits NDA for pulmonary arterial hypertension drug

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The FDA has accepted the new drug application (NDA) for inhaled treprostinil for the treatment of pulmonary arterial hypertension from United Therapeutics and its wholly-owned subsidiary Lung Rx. 

The Silver Spring, Md.-based United said its NDA will be subject to a standard review period of 10 months, with a targeted user-fee deadline of April 30, 2009. 

United Therapeutics is a biotechnology company focused on the development and commercialization of products to address the unmet medical needs of patients with chronic and life-threatening cardiovascular. Lung Rx is a biotechnology company focused on unmet medical needs in pulmonary medicine and pulmonary delivery of innovative therapeutic products.