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FDA's Thinking On New Psychiatric Endpoints: What Does Brintellix CRL Portend For Nuplazid?

Executive Summary

FDA deviated from its advisory committee's recommendation on the first cognitive function claim for an antidepressant when it issued a complete response letter for Brintellix. The decision could signal trouble for Acadia's Nuplazid for Parkinson's psychosis, which also relies on a new psychiatric endpoint.

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