United Therapeutics files new cross-claims in FDA suit challenging YUTREPIA NDA acceptance

Liquidia Corp

On Sept. 16, 2024, United Therapeutics filed new cross-claims against FDA in the existing FDA Suit.
Cross-claims re-assert challenge to FDA's acceptance of Liquidia's NDA for YUTREPIA (treprostinil).
Liquidia states it will vigorously defend its ability to launch YUTREPIA and against the allegations.
United had voluntarily dismissed a similar challenge on Aug. 20, 2024, before refiling as cross-claims.
Liquidia's prior suit challenging FDA's 3-year NCI exclusivity for Tyvaso DPI remains ongoing.

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