INDV Negative Sentiment
Indivior Statement RE: Delayed FDA Approval of SUBLOCADE® Label Changes Indivior PLC (Nasdaq/LSE: INDV) provides the following update regarding its PDUFA action date for label changes (rapid initiation protocol and...
Wednesday, February 12, 2025 BiopharmaWatch Research 1 min read Key Takeaway: Indivior PLC announced that the FDA has delayed the final review of the label changes for SUBLOCADE, originally scheduled for February 7, 2025. While the FDA accepted the proposed label with no outstanding items to address, the review process will take longer than expected. Indivior plans to provide further updates regarding the approval status of the changes as necessary. This delay could have implications for the company and its stakeholders.
Full Press Release Details
RICHMOND, Va. , Feb. 12, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV) provides the following update regarding its PDUFA action date for label changes (rapid initiation protocol and alternative injection sites) for SUBLOCADE® (buprenorphine extended-release) Injection, which was scheduled for February 7, 2025 :
Yesterday, February 11th , 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.