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# Advisory Panel to Vote on Nuplazid Resubmission
- URL: https://www.fdaweb.com/advisory-panel-to-vote-on-nuplazid-resubmission/
- Published: 2022-05-03T12:00:00.000Z
- Updated: 2026-09-14T17:43:03.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151729

*Federal Register* notice: FDA has announced a 6/17 Psychopharmacologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss and vote on an Acadia Pharmaceuticals resubmitted supplemental NDA for a new indication for its Nuplazid (pimavanserin) — treating hallucinations and delusions associated with Alzheimer’s disease psychosis. FDA issued a complete response [letter](https://www.fdaweb.com/fda-complete-response-on-nuplazid-snda/) on the firm’s original sNDA in 4/2021, raising questions about the pivotal Phase 3 HARMONY study design and citing a lack of statistical significance in some of the subgroups of dementia and insufficient numbers of patients with certain less common dementia subtypes as lack of substantial evidence of effectiveness to support approval. The agency has set an 8/4 user fee review action target date on the submission.