Last week, the U.S. Food and Drug Administration (FDA) approved Jentadueto®XR (linagliptin and metformin hydrochloride extended-release) tablets as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) for whom treatment with linagliptin and metformin is appropriate. JENTADUETO XR (2.5/1000 mg and 5/1000 mg), which is marketed by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY), is the seventh new treatment from the Boehringer Ingelheim-Lilly Diabetes alliance to be approved by the FDA in the last five years.

JENTADUETO XR should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, and has not been studied in people with a history of pancreatitis. The JENTADUETO XR label contains a boxed warning for the risk of lactic acidosis, a serious metabolic complication that can occur due to metformin accumulation during treatment with JENTADUETO XR.

The press release regarding the FDA approval is available here.