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United Therapeutics’s NDA for inhaled treprostinil accepted for FDA review

US-based biotechnology company United Therapeutics and its wholly-owned subsidiary Lung Rx, have announced that the FDA has accepted for review the new drug application for inhaled treprostinil.

The new drug application (NDA) will be subject to a standard review period of 10 months, with a targeted user fee deadline of April 30, 2009.

According to the company, inhaled treprostinil is developed for the treatment of pulmonary arterial hypertension.