MANNKIND CORP : Other Events (form 8-K)

Published: 2022-01-18 07:05:05 ET MNKD

Item 8.01. Other Events.

On October 18, 2021, United Therapeutics Corporation ("UT") issued a press release disclosing that it had received a Complete Response from the U.S. Food and Drug Administration (the "FDA") concerning UT's new drug application ("NDA") for Tyvaso DPI™. On December 27, 2021, UT disclosed that it had resubmitted the NDA to the FDA. On January 18, 2022, UT disclosed that the FDA has acknowledged acceptance of the NDA for review as a class 1 response with a user fee goal date in February 2022.

TYVASO DPI is a trademark of United Therapeutics Corporation.

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