Indivior announces FDA delay of final review of Sublocade label changes

Indivior (INDV) provided the following update regarding its PDUFA action date for label changes for Sublocade Injection, which was scheduled for February 7: The FDA informed Indivior that, following acceptance of the proposed label for Sublocade, there were no outstanding items to address, but that final review of the Sublocade label changes has been delayed. Indivior will provide further updates on the status of the approval of the proposed Sublocade label changes as appropriate.