Posted by Michael Wonder on 04 Jan 2017
U.S. FDA approves supplemental new drug applications to include landmark data in product labels for Synjardy (empagliflozin/metformin hydrochloride), Synjardy XR (empagliflozin/metformin hydrochloride extended-release) and Glyxambi (empagliflozin/linagliptin) tablets
4 January 2017 - The U.S. FDA approved supplemental new drug applications for three type 2 diabetes medicines within the empagliflozin family to include data from the landmark EMPA-REG OUTCOME trial.
The data show that empagliflozin reduced the risk for cardiovascular death compared with placebo when added to standard of care type 2 diabetes and cardiovascular medicines in adults with type 2 diabetes and established cardiovascular disease. The data have been added to the "Clinical Studies" sections of the Prescribing Information for Synjardy (empagliflozin/metformin hydrochloride), Synjardy XR (empagliflozin/metformin hydrochloride extended-release) and Glyxambi (empagliflozin/linagliptin) tablets, all of which are marketed by Boehringer Ingelheim and Eli Lilly.
