MannKind partner UT's Tyvaso DPI NDA accepted for FDA Class 1 review; goal Feb 2022

MANNKIND CORP

FDA accepted United Therapeutics' resubmitted NDA for Tyvaso DPI as a Class 1 response.
User fee goal date set for February 2022.
UT previously received a Complete Response Letter in October 2021 for the NDA.

item 8.01

MANNKIND CORP filing history →

Source: SEC EDGAR

accession 0001564590-22-001402

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