Indivior PLC Delayed FDA Approval of SUBLOCADE Label Changes
12 February 2025 - 6:00PM
RNS Regulatory News
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.
-ends-
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