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BioWorld - Friday, July 3, 2026
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Home » Tentative approval of Yutrepia still leaves Liquidia adrift
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Tentative approval of Yutrepia still leaves Liquidia adrift

Aug. 19, 2024
By Lee Landenberger
Despite the U.S. FDA’s tentative approval of Liquidia Corp.’s Yutrepia (treprostinil) for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, the company is stuck in the starting gate. Liquidia said it disagrees with the agency’s stance of simultaneously granting regulatory exclusivity in both indications to United Therapeutics Corp.’s powdered formulation of treprostinil, branded Tyvaso, until May 23, 2025. That means full approval for the inhalation powder won’t come until after that date and neither will a Yutrepia launch.
BioWorld Regulatory Cardiovascular U.S. FDA

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