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
News Market Reaction
On the day this news was published, INDV declined 2.53%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
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.
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SOURCE Indivior PLC
FAQ
What label changes are pending FDA approval for INDV's SUBLOCADE?
When was the original PDUFA date for INDV's SUBLOCADE label changes?
What did the FDA communicate to INDV about SUBLOCADE's label changes on February 11, 2025?
How will the FDA delay impact INDV's SUBLOCADE label change approval?
