Risperidone · Regulatory label update

FDA supplemental approval: Risperidone (Labeling)

U.S. Food and Drug Administration · July 1, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

This is an FDA supplemental approval record for risperidone orally disintegrating tablets in four dosage strengths (1 mg, 2 mg, 3 mg, 4 mg) from Actavis Labs FL Inc., approved on 1 July 2026. The record documents a labeling change only and does not contain clinical trial data, efficacy results, or safety findings.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval for risperidone orally disintegrating tablet labeling; does not report clinical trial outcomes or comparative efficacy.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-07-01

Dosage strengths approved1 mg, 2 mg, 3 mg, 4 mg

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
The nature of the labeling change is not specified in this record.
No comparator arm, effect size, or statistical analysis is reported.
No information on underlying evidence supporting this labeling supplement is provided.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

This is a regulatory action record, not a clinical study.

Directness

insufficient

Labeling supplement; no clinical trial data provided in this record.

Consistency

insufficient

No comparative data or prior trial results reported in this record.

Risk of bias

insufficient

Not applicable to a labeling approval record.

Sample adequacy

insufficient

No clinical population or sample size data in this regulatory submission.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application ANDA076996. This is a regulatory action record, not a clinical study. Brand name: RISPERIDONE. Active ingredient: RISPERIDONE. Sponsor: ACTAVIS LABS FL INC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-01. Products: RISPERIDONE, TABLET, ORALLY DISINTEGRATING, ORAL, RISPERIDONE 3MG; RISPERIDONE, TABLET, ORALLY DISINTEGRATING, ORAL, RISPERIDONE 1MG; RISPERIDONE, TABLET, ORALLY DISINTEGRATING, ORAL, RISPERIDONE 4MG; RISPERIDONE, TABLET, ORALLY DISINTEGRATING, ORAL, RISPERIDONE 2MG.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Actavis Labs FLRisperidone