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FDA · Drug approval ·

FDA approves dapagliflozin and metformin extended-release tablets

The FDA approved dapagliflozin and metformin extended-release tablets for adults with type 2 diabetes.

About 1 minute to readNoticePublished August 2026

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A calm illustration of a tablet and a heart next to a kidney-shaped icon, with a simple diet-and-check symbol in the background.

If you have type 2 diabetes, the Food and Drug Administration (FDA) has approved dapagliflozin and metformin hydrochloride extended-release tablets. The tablet is meant to work alongside diet and exercise to improve blood sugar control.

The label also includes dapagliflozin’s added benefits in certain conditions, including chronic kidney disease and heart failure, to help reduce risks such as kidney decline, cardiovascular death, and hospitalization for heart failure.

This product contains metformin and dapagliflozin; it is not recommended for people with type 1 diabetes, and it is limited to type 2 diabetes for all uses described on the label.