Dapagliflozin · Regulatory label update

FDA supplemental approval: Qtern (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 a U.S. FDA supplemental labeling approval for Qtern (dapagliflozin 5 or 10 mg plus saxagliptin 5 mg), dated 3 June 2026. The record confirms the product was not discontinued for safety or effectiveness reasons but does not contain clinical trial results or efficacy data.

What was studied

Regulatory label update. United States.

Key findings

Qtern tablet formulations approved: dapagliflozin 5 mg + saxagliptin 5 mg and dapagliflozin 10 mg + saxagliptin 5 mg Federal Register determination: product was not discontinued or withdrawn for safety or effectiveness reasons

Safety

This record is a regulatory action only and does not contain clinical trial results, efficacy endpoints, or adverse event analysis No comparative efficacy or safety data are reported

Who this may help

This labeling action does not provide new clinical evidence and should not be used to infer comparative efficacy or safety. Clinicians should consult the full approved product labeling and the underlying NDA clinical data for guidance on use.

Plain-language summary

FDA supplemental labeling approval for Qtern (dapagliflozin/saxagliptin); indicates label modification without new efficacy or safety trial data reported here.

Study design

As stated by the source record.

SettingUnited States

Clinical bottom line

Caveats

This record is a regulatory action only and does not contain clinical trial results, efficacy endpoints, or adverse event analysis
The specific nature of the labeling change (e.g., indication, warning, dosing modification) is not stated in this excerpt
No comparative efficacy or safety data are reported
The basis for approval (e.g., reference to prior NDA trials or new data) 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 clinical study design reported

Directness

insufficient

Labeling record does not report clinical outcomes or direct evidence

Consistency

insufficient

No comparative or replicate data provided in this record

Risk of bias

insufficient

Regulatory labeling action; bias assessment not applicable

Sample adequacy

insufficient

No trial population or sample size stated in this record

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

Source abstract

Drugs@FDA record for application NDA209091. This is a regulatory action record, not a clinical study. Brand name: QTERN. Active ingredient: DAPAGLIFLOZIN. Sponsor: ASTRAZENECA AB. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-03. Products: QTERN, TABLET, ORAL, DAPAGLIFLOZIN 5MG + SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; QTERN, TABLET, ORAL, DAPAGLIFLOZIN 10MG + SAXAGLIPTIN HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**.

Follow from this

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

DapagliflozinAstrazeneca AB