Metformin label revised for adults and children with T2D

On 2026-08-03, the FDA revised the label for Metformin Hydrochloride Tablets USP to update the indication and usage language. The updated labeling states the drug is used as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.

Background

Metformin hydrochloride is listed in this label update under several product names, including metformin hydrochloride, canagliflozin and metformin hydrochloride, Invokamet, Invokamet XR, and Invokana. The related-drug list for the event also includes dapagliflozin and empagliflozin.

What this means

This revision clarifies the labeled indication and the patient groups named in the prescribing information. For clinicians and medication reviewers, the key point is that the label now explicitly states use in adults and children with type 2 diabetes mellitus as an adjunct to diet and exercise.

Source

This information is based on an FDA label revision dated 2026-08-03. The record is available via DailyMed at dailymed.nlm.nih.gov.