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US FDA accepts United Therapeutics' application for Remodulin infusion system

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US FDA accepts United Therapeutics' application for Remodulin infusion system

The U.S. Food and Drug Administration accepted United Therapeutics Corp.'s new drug application for the implantable system for Remodulin for a 6-month review as a class 2 resubmission.

United Therapeutics said the application was originally submitted on Jan. 30, and it expects FDA action on the application by July 30.

According to an FDA filing, the implantable system for Remodulin is an infusion system that is fully implanted to supply Remodulin into the veins of a patient.

Remodulin, or treprostinil, is a drug used to treat pulmonary arterial hypertension, or high blood pressure in the arteries that go from the heart to the lungs.

The implantable system for Remodulin stops the narrowing of the pulmonary arteries, aids in delivering blood to the lungs and stabilizes the blood pressure.