On June 27, 2026, the FDA updated the indication and usage section of the label for Metformin Hydrochloride Tablets USP. The revision clarifies its role as an adjunct to diet and exercise for improving glycemic control in adults and children with type 2 diabetes mellitus.
Background
Metformin Hydrochloride is a widely used medication in the management of type 2 diabetes mellitus. Its updated label specifies that Metformin Hydrochloride Tablets USP are indicated for use as an adjunct to diet and exercise. This medication is prescribed to improve glycemic control in patients diagnosed with type 2 diabetes mellitus, encompassing both adult and pediatric populations.
What this means
The updated label for Metformin Hydrochloride Tablets USP provides a clear and current statement regarding its approved use. This revision ensures that healthcare providers have the most up-to-date information on the specific patient population—adults and children with type 2 diabetes mellitus—and the context of its use—as an adjunct to diet and exercise—for improving glycemic control. Such label revisions are standard practice by the FDA to maintain accuracy and ensure safe and effective medication use.
Source
This label revision was issued by the FDA on June 27, 2026. The updated information is available on dailymed.nlm.nih.gov, an official service of the National Library of Medicine providing information about marketed drugs.