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Liquidia Has Filed Litigation In The U.S. District Court Of The District Of Columbia That Challenges The Recent FDA Decision To Grant 3-year New Clinical Investigation Exclusivity (NCI Exclusivity) To Tyvaso DPI

2024-08-22 18:05

FDA granted tentative approval of YUTREPIA (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) patients on August 16, 2024. As a result of the FDA's award of NCI exclusivity to Tyvaso DPI, the final approval of YUTREPIA (treprostinil) inhalation powder is currently delayed until after the expiration of the exclusivity on May 23, 2025.

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