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FDA Approves Synjardy for Type 2 Diabetes
Boehringer Ingelheim and Eli Lilly announced in a news release that the US Food and Drug Administration has granted approval for a new, SGLT2 inhibitor/metformin combination drug called Synjardy for people with type 2 diabetes.
Synjardy combines the sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin with metformin hydrochloride.
It becomes the third approved drug in the United States that contains empagliflozin -- the others being Glyxambi and Jardiance -- and it is also the third SGLT2 inhibitor/metformin combination to arrive on the US market, preceded by Xigduo XR and Invokamet.
Synjardy was approved for the European market in May 2015.
The FDA has approved Synjardy as an adjunct or addition to diet and exercise in efforts to improve glycemic control in adults with type 2 diabetes who are not adequately controlled with either empagliflozin or metformin as therapies unto themselves (monotherapies), or in patients already being treated with either empagliflozin and metformin.
Synjardy is not indicated for the treatment of type 1 diabetes or diabetic ketoacidosis.
The FDA will include on Synjardy a boxed warning, as it includes with all products containing metformin, which warns about the risk of lactic acidosis.
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