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Liquidia is suing the U.S. Food and Drug Administration (FDA) to challenge a decision that delays the final approval of Yutrepia, its inhaled dry-powder formulation of treprostinil, arguing that the delay unfairly limits patient access to important treatment.
Yutrepia was granted tentative approval in 2021 to improve the ability to exercise in adults with pulmonary arterial hypertension (PAH), an indication extended earlier this month to pulmonary hypertension associated with interstitial lung disease (PH-ILD).