United Therapeutics: FDA Acknowledges Acceptance of Tyvaso DPI Application

By Will Feuer

United Therapeutics Corp. said the U.S. Food and Drug Administration has acknowledged acceptance of its new drug application for its Tyvaso DPI lung-disease treatment.

The Silver Spring, Md., biotechnology company said the FDA has accepted the application for review as a class 1 response with a user fee goal date in February.

The company is seeking approval of the drug for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, to improve exercise capacity.

The FDA in October had turned away the application, citing a single deficiency related to an open inspection issue at a third-party testing plant.

United Therapeutics said at the time that it believed the issue would be resolved quickly, paving the way for FDA approval of Tyvaso DPI by the summer of 2022. In December, it refiled its application.

Write to Will Feuer at Will.Feuer@wsj.com

(END) Dow Jones Newswires

January 18, 2022 07:30 ET (12:30 GMT)

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