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Liquidia Seeks Stay on FDA Exclusivity Approval of Rival Version of Hypertension Drug
2024-08-29 05:42
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 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 claims the exclusivity decision is harming the competition by prolonging United's "decades-long" monopoly over an active ingredient in its drug. Liquidia wants the court to hear the request for stay by no later than Sept. 17.
United Therapeutics did not immediately respond to a request for comment from MT Newswires.
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