FDA Approval Again Wanted for Nuplazid in Easing Psychosis

FDA Approval Again Wanted for Nuplazid in Easing Psychosis

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FDA Approval Again Wanted for Nuplazid in Easing Psychosis

Acadia Pharmaceuticals intends to again request that oral Nuplazid (pimavanserin) be approved to treat hallucinations and delusions, but this time only when associated with the dementia-related psychosis of Alzheimer’s disease. Its planned request to the U.S. Food and Drug Administration (FDA), in the form of a resubmitted supplemental new drug application (sNDA), follows the FDA’s rejection last year of Nuplazid in treating hallucinations and delusions in a much broader category of dementia-related psychosis. The FDA, in its response letter,…

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