FDA accepts application for Lung Rx' treprostinil
Lung Rx, the wholly-owned subsidiary of USA-based United Therapeutics, says that the US Food and Drug Administration has accepted for review the New Drug Application for its inhaled treprostinil in the treatment of pulmonary arterial hypertension. The 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 unique products to address the unmet medical needs of patients with chronic and life-threatening cardiovascular and infectious diseases and cancer. Lung Rx is focused on pulmonary medicine and pulmonary delivery of innovative therapeutic products.
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