Dapagliflozin AND Metformin Hydrochloride · Regulatory label update

FDA supplemental approval: Dapagliflozin AND Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration · August 11, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is a supplemental labeling approval by the FDA for the fixed-dose combination of dapagliflozin and metformin hydrochloride (XIGDUO XR), dated 11 August 2026. The record documents a regulatory action and product formulations but does not contain clinical trial results, efficacy data, or safety evidence.

What was studied

Regulatory label update.

Key findings

Supplemental approval granted for labeling of XIGDUO XR (dapagliflozin and metformin hydrochloride combination product)

Safety

This record is a regulatory approval document and does not contain clinical trial results, efficacy endpoints, 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 labeling approval for an existing combination product; regulatory action that does not contain clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-08-11

Product formulations approvedFour: dapagliflozin 10 mg + metformin HCl 1 g; dapagliflozin 5 mg + metformin HCl 1 g; dapagliflozin 2.5 mg + metformin HCl 1 g; dapagliflozin 10 mg + metformin HCl 500 mg

Caveats

This record is a regulatory approval document and does not contain clinical trial results, efficacy endpoints, safety data, or comparative evidence.
The specific nature of the labeling change is not detailed in the record.
No sample size, study design, or outcome measures are reported.

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 clinical study design reported.

Directness

insufficient

Labeling record does not report clinical outcomes or trial endpoints.

Consistency

insufficient

No comparative data or replication data provided in record.

Risk of bias

insufficient

Regulatory approval record; bias assessment not applicable or reported.

Sample adequacy

insufficient

No patient cohort or sample size reported in approval action.

Source abstract

Drugs@FDA record for application NDA205649. This is a regulatory action record, not a clinical study. Brand name: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE. Active ingredient: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE. Sponsor: ASTRAZENECA AB. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-11. Products: XIGDUO XR, TABLET, EXTENDED RELEASE, ORAL, DAPAGLIFLOZIN 10MG + METFORMIN HYDROCHLORIDE 1GM; XIGDUO XR, TABLET, EXTENDED RELEASE, ORAL, DAPAGLIFLOZIN 5MG + METFORMIN HYDROCHLORIDE 1GM; XIGDUO XR, TABLET, EXTENDED RELEASE, ORAL, DAPAGLIFLOZIN 2.5MG + METFORMIN HYDROCHLORIDE 1GM; XIGDUO XR, TABLET, EXTENDED RELEASE, ORAL, DAPAGLIFLOZIN 10MG + METFORMIN HYDROCHLORIDE 500MG.

Follow from this

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

Astrazeneca ABDapagliflozin AND Metformin Hydrochloride