Alogliptin AND Metformin Hydrochloride · Regulatory label update

FDA supplemental approval: Kazano (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

The FDA approved a supplemental labeling change for Kazano (alogliptin and metformin) on 11 August 2026. This is a regulatory action record that documents an approval decision but does not contain clinical trial results, efficacy data, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Safety

This record reports only a regulatory labeling action and does not contain clinical trial data, efficacy results, or comparative safety evidence. No patient outcomes, adverse events, or efficacy metrics are reported.

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 an existing combination antidiabetic product; no clinical trial data or efficacy outcomes reported.

Caveats

This record reports only a regulatory labeling action and does not contain clinical trial data, efficacy results, or comparative safety evidence.
The specific labeling changes made are not detailed in this record.
No patient outcomes, adverse events, or efficacy metrics 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 record; no study design applies.

Directness

insufficient

No clinical outcomes, efficacy data, or direct evidence presented.

Consistency

insufficient

Single regulatory action; no comparative or replicative data.

Risk of bias

insufficient

Regulatory record; bias assessment not applicable.

Sample adequacy

insufficient

No patient population studied in this record.

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 NDA203414. This is a regulatory action record, not a clinical study. Brand name: KAZANO. Active ingredient: ALOGLIPTIN AND METFORMIN HYDROCHLORIDE. Sponsor: TAKEDA PHARMS USA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-11. Products: KAZANO, TABLET, ORAL, ALOGLIPTIN BENZOATE EQ 12.5MG BASE + METFORMIN HYDROCHLORIDE 500MG; KAZANO, TABLET, ORAL, ALOGLIPTIN BENZOATE EQ 12.5MG BASE + METFORMIN HYDROCHLORIDE 1GM.

Follow from this

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

Takeda Pharms UAlogliptin AND Metformin Hydrochloride