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

Rhea-AI Summary

Indivior PLC (Nasdaq/LSE: INDV) announced that the FDA has delayed the final review of proposed label changes for SUBLOCADE® (buprenorphine extended-release) Injection. The PDUFA action date was originally scheduled for February 7, 2025. On February 11, 2025, the FDA informed Indivior that while there were no outstanding items to address following acceptance of the proposed label, the final review has been delayed. The proposed changes include rapid initiation protocol and alternative injection sites. The company will provide updates on the approval status as appropriate.

Positive

• FDA confirmed no outstanding items to address in the proposed label

Negative

• FDA delayed final review of SUBLOCADE label changes beyond scheduled PDUFA date
• Uncertainty in timeline for label change approval

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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.

View original content to download multimedia:https://www.prnewswire.com/news-releases/indivior-statement-re-delayed-fda-approval-of-sublocade-label-changes-302374307.html

SOURCE Indivior PLC

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What label changes are pending FDA approval for INDV's SUBLOCADE?

The pending label changes for SUBLOCADE include rapid initiation protocol and alternative injection sites.

When was the original PDUFA date for INDV's SUBLOCADE label changes?

The original PDUFA action date for SUBLOCADE label changes was February 7, 2025.

What did the FDA communicate to INDV about SUBLOCADE's label changes on February 11, 2025?

The FDA informed Indivior that while there were no outstanding items to address following acceptance of the proposed label, the final review has been delayed.

How will the FDA delay impact INDV's SUBLOCADE label change approval?

The delay creates uncertainty in the timeline for final approval of SUBLOCADE's label changes, though the FDA has confirmed there are no outstanding items to address.