United Therapeutics resubmits Tyvaso DPI NDA to FDA after CRL

MANNKIND CORP

UT received a Complete Response Letter from FDA on Oct 18, 2021 for Tyvaso DPI.
UT disclosed on Dec 27, 2021 that it has resubmitted the NDA to FDA.
Tyvaso DPI uses MannKind's Inhalation technology; resubmission is a key regulatory milestone.

item 8.01

MANNKIND CORP filing history →

Source: SEC EDGAR

accession 0001564590-21-061212

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