Metformin Hydrochloride · Regulatory label update

FDA supplemental approval: 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

The FDA approved a supplemental labeling application for metformin hydrochloride extended-release tablets (500 mg and 750 mg) from MacLeods Pharmaceuticals on 11 August 2026. This record documents a regulatory action only and does not contain clinical trial results, efficacy data, or safety comparative analysis.

What was studied

Regulatory label update.

Key findings

Supplemental labeling approval granted for metformin hydrochloride extended-release tablets, 500 mg and 750 mg formulations

Safety

This is a regulatory record and does not contain clinical trial results, efficacy data, or safety comparisons.

Who this may help

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

Plain-language summary

This is an FDA supplemental approval action for metformin hydrochloride labeling; it documents a regulatory decision, not clinical trial evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-08-11

Formulation strengths approved500 mg and 750 mg extended-release tablets

Caveats

This is a regulatory record and does not contain clinical trial results, efficacy data, or safety comparisons.
The specific labeling changes are not detailed in this record.
No information on patient populations, indications, or clinical outcomes is provided.

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 record, not a clinical study.

Directness

insufficient

Regulatory action; does not report clinical trial data or outcomes.

Consistency

insufficient

No comparative or confirmatory data presented in this record.

Risk of bias

insufficient

Not applicable; this is an administrative approval record.

Sample adequacy

insufficient

No study population or trial data reported.

Source abstract

Drugs@FDA record for application ANDA206955. This is a regulatory action record, not a clinical study. Brand name: METFORMIN HYDROCHLORIDE. Active ingredient: METFORMIN HYDROCHLORIDE. Sponsor: MACLEODS PHARMS. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-11. Products: METFORMIN HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, METFORMIN HYDROCHLORIDE 750MG; METFORMIN HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, 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.

Macleods PharmsMetformin Hydrochloride