FDA Approves New Combination Drug for Type 2 Diabetes

The FDA has approved Synjardy XR (empagliflozin and metformin hydrochloride extended-release) tablets for the treatment of adults with type 2 diabetes.

The drug is intended for use in combination with diet and exercise. It is comprised of empagliflozin, a sodium-glucose co-transporter 2 inhibitor, and metformin.
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The approval was based upon the results clinical trials on the effects of co-administration of empagliflozin and metformin, alone or in combination with sulfonylurea. It is not intended for use in patients with type 1 diabetes.

Potential adverse effects include lactic acidosis, dehydration, low blood pressure, and ketoacidosis. Common side effects include diarrhea, nausea, vomiting, stomach pain, indigestion, weakness, and headache.

—Michael Potts

Reference:

Eli Lilly and Company. US FDA approves Synjardy® XR (empagliflozin/metformin hydrochloride extended-release) tablets for adults with type 2 diabetes [press release]. http://www.prnewswire.com/news-releases/us-fda-approves-synjardy-xr-empagliflozinmetformin-hydrochloride-extended-release-tablets-for-adults-with-type-2-diabetes-300376704.html. Published December 12, 2016. Accessed December 13, 2016.