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news.Merck, known as MSD outside the US and Canada, has received FDA approval for JANUMET XR (sitagliptin and metformin hydrochloride (HCl) extended-release) tablets for type 2 diabetes.
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JANUMET XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both sitagliptin and extended-release metformin is appropriate.
The approval was based upon a clinical bioequivalence study that demonstrated that administration of JANUMET XR was equivalent to co-administration of corresponding doses of sitagliptin and metformin HCl extended- release.
Merck diabetes and endocrinology vice president Barry Goldstein said JANUMET XR is a new treatment that adds once-daily convenience to the powerful efficacy of JANUMET for patients with type 2 diabetes.
"This is important because many patients with type 2 diabetes require treatment with multiple drugs to maintain blood sugar control," Goldstein added.