UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM
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CURRENT REPORT
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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.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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MannKind Corporation |
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Date: January 18, 2022 |
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By: |
/s/ David Thomson, Ph.D., J.D. |
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David Thomson, Ph.D., J.D. |
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Corporate Vice President, General Counsel and Secretary |