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US FDA, Actavis, Salix, prevail on Norwich’s APA case over ANDA tentative approval

By Melissa Ritti ( April 21, 2025, 15:24 GMT | Insight) -- Litigation by Norwich Pharmaceuticals over the US Food and Drug Administration’s decision to grant its application for generic rifaximin only tentative approval cratered last week when a District of Columbia federal judge said that under the current statutory regime, no violation of the Administrative Procedure Act has occurred. But the court was not without sympathy, conceding the case “may evince the need” for legislation “that better balances the need for increased speed at which the FDA grants approval of generic drugs and rewards for the first generic manufacturer that challenges patents covering a brand name drug.” Norwich has already given notice of its intent to appeal.The US Food and Drug Administration and intervenors Actavis Laboratories FL and Salix Pharmaceuticals prevailed last week in a lawsuit by Norwich Pharmaceuticals over the FDA’s decision to grant it only tentative approval for generic rifaximin....

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