Liquidia sues FDA over Tyvaso DPI exclusivity blocking YUTREPIA approval

Liquidia Corp

FDA granted tentative approval of YUTREPIA on Aug 16, 2024, but final approval delayed until after May 23, 2025.
Liquidia filed suit in D.C. District Court (Case No. 1:24-cv-02428) challenging FDA's 3-year NCI exclusivity for Tyvaso DPI.
United Therapeutics voluntarily dismissed its complaint challenging FDA's acceptance of Liquidia's amended NDA on Aug 20.
Liquidia argues FDA's decision violates congressional intent and seeks to vacate exclusivity to allow timely market entry.

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