(RTTNews) - Indivior PLC (INDV, INDV.L), a specialty pharmaceutical company, announced Wednesday that the U.S. Food and Drug Administration has informed that the final review of the SUBLOCADE (buprenorphine extended-release) label changes has been delayed.
SUBLOCADE is a prescription medicine used to treat adults with moderate to severe addiction/dependence to opioid drugs - prescription or illegal.
The company informed the delay in its update regarding its PDUFA action date for label changes (rapid initiation protocol and alternative injection sites) for SUBLOCADE Injection. The action date was scheduled for February 7.
Meanwhile, on Tuesday, the FDA informed Indivior that, following acceptance of the proposed label for SUBLOCADE, there were no outstanding items to address, but that final review has been delayed.
Indivior plans to provide further updates on the status of the approval of the proposed SUBLOCADE label changes as appropriate.
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