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Letter to the FDA Opposing Approval of Brexpiprazole for the Treatment of Agitation Associated with Alzheimer’s Dementia

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In a letter to the Food and Drug Administration (FDA), Public Citizen urged FDA to reject brexpiprazole for the treatment of agitation associated with Alzheimer’s dementia because the drug’s small benefits do not outweigh its significant risks and because no population for which the benefits would outweigh the risks was identified.

May 10, 2023, FDA acknowledgment letter.