Inhaled Treprostinil New Drug Application Filed By FDA

Main Category: Hypertension
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 05 Sep 2008 - 2:00 PDT

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United Therapeutics Corporation (Nasdaq: UTHR) and its wholly-owned subsidiary Lung Rx, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for inhaled treprostinil for 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 Corporation 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, Inc. is a biotechnology company focused on unmet medical needs in pulmonary medicine and pulmonary delivery of innovative therapeutic products. [uthr-g]

United Therapeutics Corporation
http://www.unither.com