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SILVER SPRING, MD, USA I March 25, 2013 I United Therapeutics Corporation (NASDAQ: UTHR) announced today that it received a second complete response letter from the United States Food and Drug Administration (FDA) declining to approve its new drug application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension (PAH).

Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics commented, "We remain confident that oral treprostinil will play an important role in treating PAH and we are committed to working collaboratively with the FDA to accomplish this goal in the most timely and appropriate manner."

United Therapeutics intends to immediately request an "end of review" meeting with the FDA to discuss this complete response letter.

About United Therapeutics

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 conditions.

SOURCE: United Therapeutics

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