Boehringer Ingelheim and Eli Lilly announced that the Food and Drug Administration (FDA) has approved Synjardy (empagliflozin, metformin HCl) as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are not adequately controlled on a regimen containing empagliflozin or metformin, or in patients already being treated with both empagliflozin and metformin.
The FDA approval is based on results from multiple clinical trials examining the co-administration of empagliflozin and metformin, alone or in combination with sulfonylurea, in the treatment of adults with type 2 diabetes. Synjardy contains empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin, a biguanide. It is not for the treatment of type 1 diabetes or diabetic ketoacidosis.
The drug label contains a boxed warning on the risk of lactic acidosis during treatment with Synjardy. It will be supplied as 5mg/500mg, 5mg/1000mg, 12.5mg/500mg, and 12.5mg/1000mg strength tablets in 60- and 180-count bottles.