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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.