Liquidia vs United Therapeutics Decision
Apr 1, 2024 12:05:14 GMT -5
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Post by otherottawaguy on Apr 1, 2024 12:05:14 GMT -5
09:58 AM EDT, 04/01/2024 (MT Newswires) -- Liquidia (LQDA) said Monday that a US court has set aside an injunction that had prohibited the US Food and Drug Administration from issuing final approval of Liquidia's amended new drug application for Yutrepia inhalation powder.
Liquidia said Yutrepia was tentatively approved by the FDA in November 2021 to treat pulmonary arterial hypertension. Liquidia amended its NDA in July 2023 so that it could also be used to treat pulmonary hypertension associated with interstitial lung disease.
United Therapeutics (UTHR) sued the FDA to prevent it from approving the amended NDA as its Tyvaso had exclusive rights to treat pulmonary hypertension associated with interstitial lung disease. However, those exclusive rights expired on Sunday, according to Liquidia.
Liquidia said United Therapeutics has appealed the decision to set aside the injunction, and has filed two separate lawsuits seeking new injunctions against Yutrepia.
Representatives for United Therapeutics did not immediately respond to a request for comment from MT Newswires.
Liquidia said Yutrepia was tentatively approved by the FDA in November 2021 to treat pulmonary arterial hypertension. Liquidia amended its NDA in July 2023 so that it could also be used to treat pulmonary hypertension associated with interstitial lung disease.
United Therapeutics (UTHR) sued the FDA to prevent it from approving the amended NDA as its Tyvaso had exclusive rights to treat pulmonary hypertension associated with interstitial lung disease. However, those exclusive rights expired on Sunday, according to Liquidia.
Liquidia said United Therapeutics has appealed the decision to set aside the injunction, and has filed two separate lawsuits seeking new injunctions against Yutrepia.
Representatives for United Therapeutics did not immediately respond to a request for comment from MT Newswires.