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United Therapeutics, Mannkind Fall After FDA Declines to Approve Lung Drug By Investing.com

by Mike Robinson

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Sam Boughedda

Investing.com — United Therapeutics Corporation (NASDAQ:) application was not approved by the U.S. Food and Drug Administration MannKind Corp . (NASDAQ:) For new drug approval to treat lung diseases, please cite inspection problems at a third-party plant.

There were no other shortcomings. MannKind shares plunged 18% while United Therapeutics’ fell 3%

Tyvaso DPI is currently being tested for pulmonary arterial hypertension and pulmonary hypertension associating with interstitial lung diseases (PHILD). It is a United Therapeutics approved Tyvaso with MannKind’s portable inhaler.

MannKind claimed that issues surrounding the trial didn’t concern them and that there weren’t any concerns about its Connecticut facility. They are still working toward approval.

“We continue to build pre-launch inventory of Tyvaso DPI and look forward to supporting United Therapeutics’ efforts in securing approval of Tyvaso DPI in the coming months,” said Michael Castagna, CEO of MannKind Corporation.

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