United Therapeutics Corp. on Monday said it has resubmitted its application seeking U.S. Food and Drug Administration approval of Tyvaso DPI lung-disease treatment.
The Silver Spring, Md., biotechnology 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.
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