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United sues FDA to try to block rival’s drug application

February 22, 2024


In an unusual move, United Therapeutics has filed a lawsuit against the FDA which claims the regulator is sidestepping established norms in allowing rival Liquidia to file for approval of a competitor to its Tyvaso product.

The suit claims that the FDA “mistakenly permitted Liquidia…to skirt longstanding FDA rules, precedents, and procedures on how pending drug approval applications are handled by the agency.”

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