FDA Approves Merck's New Type 2 Diabetes Treatment
The FDA has approved Merck's Janumet XR tablets, a new treatment for type 2 diabetes that combines sitagliptin with extended-release metformin.
The US FDA has approved Merck's Janumet XR tablets as a new treatment for type 2 diabetes.
Janumet XR combines sitagliptin, the active component of Januvia, with extended-release metformin in order to provide a once-daily treatment option for patients needing to control their blood sugar.
The drug received approval based upon the results of a clinical bioequivalence study, which demonstrated that the use of Janumet XR was equivalent to co-administration of corresponding doses of sitagliptin and metformin HCI extended-release.
The drug will come with a boxed warning for lactic acidosis, a rare complication that can occur due to metformin accumulation.
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