Synjardy empagliflozin/metformin regulatory update

FDA approved an NDA from Boehringer for Synjardy empagliflozin/metformin to treat adults with Type II diabetes. Specifically, the drug is indicated as an adjunct to diet and exercise to improve glycemic control in patients who are not adequately controlled on a regimen containing empagliflozin or metformin or patients already being treated with empagliflozin and metformin. The label for the combination of Jardiance empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and immediate-release metformin includes a boxed warning for the risk of lactic acidosis. Jardiance is approved in the U.S. and EU. ...