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Eagle Swats More Vasopressin Hurdles As Petition And Injunction Are Denied

FDA Intends To Refer Par Citizen Petition To US Federal Trade Commission

 
• By Dean Rudge

In a clean sweep for Eagle Pharmaceuticals, following its recent approval for the first generic version of Par’s Vasostrict, the ANDA sponsor has seen defeated a Par citizen petition and dodged injunctive action launched by the Endo subsidiary.

Sign outside of FDA's headquarters in White Oak, MD
Par's petition did not raise "valid or scientific regulatory issues" • Source: Alamy

Eagle Pharmaceuticals has knocked down further potential hurdles to introducing the first generic to Par’s Vasostrict (vasopressin) 20 units/ml injectable in the US, with the potential for a lucrative 180-day generic market exclusivity period, following recent US Food and Drug Administration approval of its ANDA.

The FDA has denied the Endo subsidiary’s citizen petition asking the agency not to approve generic Vasostrict products until certain were met, taking particular and unusual umbrage with the originator in the process as it

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