Judge Andrews removes Hatch-Waxman injunction, allowing FDA to approve Liquidia's NDA for YUTREPIA™.
Judge Andrews removes injunction in Hatch-Waxman litigation, clearing path for potential FDA approval of YUTREPIA™ (treprostinil) inhalation powder. Liquidia Corporation announces legal and regulatory progress, including expiry of Tyvaso®'s regulatory exclusivity for PH-ILD treatment. U.S. Food and Drug Administration (FDA) no longer enjoined from issuing final approval for Liquidia's New Drug Application (NDA) for YUTREPIA™.
April 01, 2024
6 Articles