# 2025-10989: FDA Schedules Public Review of REXULTI Drug Application

2025-10989, Psychopharmacologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental New Drug Application (sNDA) 205422/S-012 for REXULTI (brexpiprazole) Tablets, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-06-17, effective 2025-07-18 (as of 2026-11-03).

- Canonical: https://policyrisk.com/federal-register/2025-10989
- As of: 2026-11-03
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-10989
- Title: Psychopharmacologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental New Drug Application (sNDA) 205422/S-012 for REXULTI (brexpiprazole) Tablets
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 25619
- Published: 2025-06-17
- Effective: 2025-07-18
- Comments close: not stated
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-11-03

## In one line

FDA Schedules Public Review of REXULTI Drug Application

## Summary

The FDA is holding a public meeting on July 18, 2025, to discuss a new update for REXULTI (brexpiprazole) tablets, a medicine that affects the brain. They want your thoughts before the meeting, so you can share comments online by July 17. This is important for patients, doctors, and drug makers because it could change how REXULTI is used or approved.

## Abstract

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

## Effects PRIA read

No economic effects identified for this document.

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## Sources
- [2025-10989 on federalregister.gov](https://www.federalregister.gov/documents/2025/06/17/2025-10989/psychopharmacologic-drugs-advisory-committee-notice-of-meeting-establishment-of-a-public-docket)
- [2025-10989 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-06-17/pdf/2025-10989.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2025-10989 (as of 2026-11-03).