3 February 2012 - Merck & Co Inc (NYSE:MRK) said on Thursday that the US Food and Drug Administration (FDA) has given the green light to the commercialisation of JANUMET XR (sitagliptin and metformin hydrochloride (HCl) extended-release) tablets for the treatment of Type 2 diabetes that combines sitagliptin, which is the active component of JANUVIA (sitagliptin), with extended-release metformin.

JANUMET XR is indicated as an addition to special diet and exercise to improve glycaemic control in adults with Type 2 diabetes mellitus when treatment with both sitagliptin and extended-release metformin is appropriate.

The FDA approval for JANUMET XR was based on the results of a clinical bioequivalence study showing that treatment with JANUMET XR was equivalent to co-administration of corresponding doses of the two individual medications, sitagliptin and metformin HCl extended-release. Extended-release metformin was as effective as immediate-release metformin.