Canagliflozin · Regulatory label update

FDA supplemental approval: Invokana (Labeling)

U.S. Food and Drug Administration · June 3, 2026

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AI Summary

This is a U.S. FDA supplemental approval action for a labeling change to canagliflozin (Invokana), approved 3 June 2026. The record does not contain clinical trial data, efficacy outcomes, safety results, or the specific nature of the labeling modification.

What was studied

Regulatory label update.

Key findings

Safety

This record reports a regulatory action only and does not contain clinical trial results, efficacy data, or safety outcome numbers.

Who this may help

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

Plain-language summary

FDA supplemental labeling approval for canagliflozin; this is a regulatory action, not a clinical study, and does not report efficacy or safety trial outcomes.

Caveats

This record reports a regulatory action only and does not contain clinical trial results, efficacy data, or safety outcome numbers.
The specific labeling change requested or approved is not described in the source text.
No comparator, control group, or comparative benefit data are provided.
The rationale for the supplemental submission is not disclosed in this record.

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

Regulatory action; no study design applicable

Directness

insufficient

Labeling change only; clinical evidence not reported in record

Consistency

insufficient

Single regulatory submission; no comparative data provided

Risk of bias

insufficient

Regulatory submission; risk of bias assessment not applicable

Sample adequacy

insufficient

Regulatory action; no sample data reported

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

Source abstract

Drugs@FDA record for application NDA204042. This is a regulatory action record, not a clinical study. Brand name: INVOKANA. Active ingredient: CANAGLIFLOZIN. Sponsor: JANSSEN PHARMS. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-03. Products: INVOKANA, TABLET, ORAL, CANAGLIFLOZIN 300MG; INVOKANA, TABLET, ORAL, CANAGLIFLOZIN 100MG.

Follow from this

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

CanagliflozinJanssen Pharms