Looks Like FDA Delay Will Cause Gap Down Opening | MNKD Message Board Posts


MannKind Corporation

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Msg  17681 of 17696  at  10/18/2021 6:27:36 AM  by

gooduntilclose


Looks Like FDA Delay Will Cause Gap Down Opening

 WESTLAKE VILLAGE, Calif. and DANBURY, Conn., Oct. 18, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, has learned that the U.S. Food and Drug Administration (FDA) issued a complete response to United Therapeutics Corporation regarding the New Drug Application (NDA) for Tyvaso DPI™ for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA declined to approve the NDA at this time, noting only one deficiency related to an open inspection issue at a third-party analytical testing center for treprostinil drug substance, the active ingredient of Tyvaso DPI. The complete response did not pertain to MannKind, and no issues were cited by the FDA as it relates to MannKind’s facility in Connecticut for manufacturing, testing and packaging of finished Tyvaso DPI, including its associated device.

“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, PharmD, Chief Executive Officer of MannKind Corporation.



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