United Therapeutics New Drug Application Declined Pending Inspection Issue

By Matt Grossman

United Therapeutics Corp.'s Tyvaso drug application wasn't approved by the Food and Drug Administration, but the issue cited by the agency can be resolved in the coming months, the company said Monday.

United Therapeutics had applied for Tyvaso's approval to treat pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. The FDA declined the application because of an open inspection issue at a third-party facility that performs analytical testing, the company said.

"We are confident that the single deficiency identified in the complete response will be resolved quickly and that Tyvaso DPI can receive approval by the summer of 2022, if not earlier," United Therapeutics Chairman and Chief Executive Martine Rothblatt said.

Chief Operating Officer Michael Benkowitz said the Silver Spring, Md.-based pharmaceutical company is standing by its goal of reaching 25,000 patients on its products by the end of 2025.

Write to Matt Grossman at matt.grossman@wsj.com

(END) Dow Jones Newswires

October 18, 2021 06:28 ET (10:28 GMT)

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