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United Therapeutics, Mannkind Fall After FDA Declines to Approve Lung Drug

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By Sam Boughedda

Investing.com — The U.S. Food and Drug Administration did not approve United Therapeutics Corporation's (NASDAQ:UTHR), application with MannKind Corp . (NASDAQ:MNKD) for new drug approval for a lung disease treatment, citing inspection issues at a third party plant.

No other deficiencies were cited. MannKind shares fell 18% and United Therapeutics fell 3%.

Tyvaso DPI is in trials to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). It uses United Therapeutics' approved Tyvaso, with MannKind's portable inhaler.

MannKind said that the issues regarding the trial did not pertain to them, and there were no issues regarding its facility in Connecticut. The companies continue to work 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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