Indivior's Monthly Injectable Buprenorphine Wins Panel Backing; US FDA May Limit Dosage

Advisory committee votes 18 to 1 for approval of the opioid abuse disorder treatment with restricted distribution; members advise post-market studies, registry.

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While several members expressed concerns about the data supporting the safety and efficacy of Indivior PLC's once-monthly injectable buprenorphine, a US FDA advisory panel voted 18 to 1 in favor of its approval with a Risk Evaluation and Mitigation Strategy (REMS) restricting distribution to certain healthcare settings.

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