Risperidone · Regulatory label update

FDA supplemental approval: Risperidone (Labeling)

U.S. Food and Drug Administration · May 7, 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 of labeling changes for risperidone tablets (0.25 mg, 0.5 mg, 1 mg, and 3 mg oral formulations) held by Heritage Pharma Avet, approved on 7 May 2026. The record does not specify what labeling modifications were authorised or the clinical or safety rationale behind them.

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 of labeling changes for risperidone tablets; this is a regulatory action record, not a clinical trial, and does not report efficacy or safety trial outcomes.

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-07

Dosage strengths approved0.25 mg, 0.5 mg, 1 mg, 3 mg tablets

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
The specific labeling changes authorised are not described in this record.
No information on the rationale or clinical evidence underlying the labeling supplement is provided.
This is a regulatory filing record only; it does not describe the drug's clinical use, efficacy, or comparative benefit.

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, not a clinical study.

Directness

insufficient

Record does not state what labeling changes were made or their rationale.

Consistency

insufficient

No comparative or confirmatory data provided in this record.

Risk of bias

insufficient

Regulatory approval record; bias assessment not applicable.

Sample adequacy

insufficient

No clinical trial data or sample reported in this record.

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 ANDA076228. This is a regulatory action record, not a clinical study. Brand name: RISPERIDONE. Active ingredient: RISPERIDONE. Sponsor: HERITAGE PHARMA AVET. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-07. Products: RISPERIDONE, TABLET, ORAL, RISPERIDONE 0.5MG; RISPERIDONE, TABLET, ORAL, RISPERIDONE 3MG; RISPERIDONE, TABLET, ORAL, RISPERIDONE 1MG; RISPERIDONE, TABLET, ORAL, RISPERIDONE 0.25MG.

Follow from this

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

Heritage Pharma AvetRisperidone