Biotechnology company United Therapeutics Corporation (UTHR) Monday said it received a second complete response letter from the United States Food and Drug Administration or FDA declining to approve its new drug application for treprostinil diolamine extended release tablets for the treatment of pulmonary arterial hypertension. The company has planned to immediately request an "end of review" meeting with the FDA to discuss this complete response letter.
However, Martine Rothblatt, chief executive officer of United Therapeutics said, "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."
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