United Therapeutics submits NDA for pulmonary arterial hypertension drug

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.

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