Combo of metformin and dapagliflozin approved

A once-daily combination pill of dapagliflozin and metformin HCl extended-release (Xigduo XR) was recently approved by the FDA.

The drug is approved to improve glycemic control in adults with type 2 diabetes when treatment with both dapagliflozin and metformin is appropriate. It is not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis, and it carries a boxed warning about the risk of lactic acidosis associated with metformin. It comes in 4 strengths: 5 mg dapagliflozin/500 mg metformin, 5 mg dapagliflozin/1000 mg metformin, 10 mg dapagliflozin/500 mg metformin, and 10 mg dapagliflozin/1000 mg metformin.

It is the first once-daily combination of a sodium-glucose cotransporter 2 inhibitor and metformin to be approved by the FDA, according to a manufacturer press release.