UTHR - MannKind says FDA extends deadline to review Tyvaso DPI

MannKind (NASDAQ:MNKD) said the U.S. Food and Drug Administration (FDA) has extended its deadline to May from February to review United Therapeutics' (NASDAQ:UTHR) new drug application (NDA) for Tyvaso DPI. The FDA had requested United Therapeutics additional information regarding the pulmonary safety of Tyvaso DPI related to a pending Citizen Petition. MannKind said United Therapeutics responded to the FDA request but the U.S. regulator considers the response to be a major amendment to the NDA and thus extended the deadline to complete its review. In October 2021, the FDA declined the approval of Tyvaso DPI for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

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MannKind says FDA extends deadline to review Tyvaso DPI