REG - Indivior PLC - Delayed FDA Approval of SUBLOCADE Label Changes

IndiviorAnnouncement

12/02/2025 07:00

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RNS Number : 7798W  Indivior PLC  12 February 2025

RNS STATEMENT RE: DELAYED FDA APPROVAL of SUBLOCADE LABEL CHANGES

 

 

RELEASE DATE:      FEBRUARY 12, 2025

RELEASE TIME:       7:00 AM GMT

 

 

Indivior 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.

 

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