Dapagliflozin · Regulatory label update

FDA supplemental approval: Farxiga (Labeling)

U.S. Food and Drug Administration · June 3, 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 action for a labeling change to Farxiga (dapagliflozin) submitted by AstraZeneca on 3 June 2026. The record does not contain clinical trial results, efficacy data, safety findings, or the specific nature of the labeling modification approved.

What was studied

Regulatory label update.

Key findings

Safety

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

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling change to dapagliflozin; does not report clinical trial data or efficacy outcomes.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-03

Application numberNDA202293

Active ingredientDapagliflozin

Formulations approvedTablet, oral, 5 mg and 10 mg

Caveats

This record does not contain clinical trial results, efficacy outcomes, safety data, or comparative evidence.
The specific content of the labeling change is not described in this regulatory record.
No information on indication, patient population, dosing rationale, or clinical context is provided.
The approval status and date alone do not convey the medical or clinical significance of the change.

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

Labeling record does not describe clinical evidence or outcomes.

Consistency

insufficient

No comparative data or prior studies referenced in this record.

Risk of bias

insufficient

Regulatory action record; bias assessment not applicable.

Sample adequacy

insufficient

No sample size or study population data provided in 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 NDA202293. This is a regulatory action record, not a clinical study. Brand name: FARXIGA. Active ingredient: DAPAGLIFLOZIN. Sponsor: ASTRAZENECA AB. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-03. Products: FARXIGA, TABLET, ORAL, DAPAGLIFLOZIN 10MG; FARXIGA, TABLET, ORAL, DAPAGLIFLOZIN 5MG.

Follow from this

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

DapagliflozinAstrazeneca AB