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FDA again delays approval of United Therapeutics drug

Drugmaker United Therapeutics announced Monday that federal regulators have again delayed approval for its experimental oral treatment for pulmonary hypertension.

United Therapeutics said it has received a second Complete Response Letter from the Food and Drug Administration, which is what the agency issues when its review process is complete and a drug application is not ready for approval.

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

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