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FDA deals setback to Silver Spring-based United Therapeutics

United Therapeutics Corp., of Silver Spring, received a setback from the Food and Drug Administration when federal regulators, for the second time, rejected the biopharmaceutical company’s new drug application for oral treprostinil, a treatment for pulmonary arterial hypertension, which is high blood pressure in the arteries that supply the lungs.

The company said it will request an immediate meeting with the FDA to review and discuss the rejection, which came in the form of a “complete response letter.”

Last October the FDA rejected the company’s request for a new drug application on grounds that there were questions about the oral drug’s effectiveness, according to Bloomberg News.