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Liquidia Seeks Stay on FDA Exclusivity Approval of Rival Version of Hypertension Drug
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Liquidia Seeks Stay on FDA Exclusivity Approval of Rival Version of Hypertension Drug
Sep 1, 2024 12:15 AM

05:42 PM EDT, 08/28/2024 (MT Newswires) -- Liquidia ( LQDA ) is seeking a preliminary injunction on an Aug. 16 decision by the US Food and Drug Administration to keep its Yutrepia drug off the market until the exclusivity period for a rival medication expires May next year, according to court documents filed Tuesday.

Liquidia ( LQDA ) sued the FDA last week in US District Court for the District of Columbia after the agency gave tentative approval to Yutrepia, but kept it from selling the inhaled powder--to treat pulmonary arterial hypertension--until the exclusivity period for a similar drug developed by United Therapeutics ( UTHR ) expires on May 23, 2025.

Liquidia ( LQDA ) claims the exclusivity decision is harming the competition by prolonging United's "decades-long" monopoly over an active ingredient in its drug. Liquidia ( LQDA ) wants the court to hear the request for stay by no later than Sept. 17.

United Therapeutics ( UTHR ) did not immediately respond to a request for comment from MT Newswires.

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