United Therapeutics NDA For Tyvaso DPI Accepted For Priority Review

United Therapeutics Corporation (UTHR) Wednesday said that the U.S. Food and Drug Administration has accepted for priority review the New Drug Application (NDA) for Tyvaso DPI for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

Tyvaso DPI is a next-generation dry powder formulation of Tyvaso.

United Therapeutics expects the review to be complete in October 2021. FDA has hinted that they have not found any potential review issues at this time, the company said.

The FDA has communicated to the company that the approval of NDA will be subject to an inspection of the products' manufacturing facility by MannKind Corporation.

"If approved, Tyvaso DPI will represent yet another path to help us achieve our goal of serving 25,000 patients by the end of 2025," said Martine Rothblatt, Chairperson and Chief Executive Officer of United Therapeutics.

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