Indivior Statement RE: Delayed FDA Approval of SUBLOCADE® Label Changes

Core Points - Indivior PLC announced a delay in the final review of the label changes for SUBLOCADE, which was initially scheduled for February 7, 2025 [1] - The FDA confirmed that there were no outstanding items to address regarding the proposed label for SUBLOCADE [1] - Indivior will provide further updates on the approval status of the proposed label changes as necessary [2]