FDA okays Merck's Janumet XR for Type 2 diabetes


Singapore, Feb 06, 2012: Merck, known as MSD outside the United States and Canada, has announced that the US Food and Drug Administration (FDA) has approved JANUMET XR (sitagliptin and metformin hydrochloride extended-release) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of JANUVIA (sitagliptin), with extended-release metformin. JANUMET XR provides a convenient once-daily treatment option for healthcare providers and patients who need help to control their blood sugar.

JANUMET XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and extended-release metformin is appropriate. JANUMET XR should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUMET XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET XR.

The FDA approved JANUMET XR based upon a clinical bioequivalence study that demonstrated that administration of 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.

“JANUMET XR is a new treatment that adds once-daily convenience to the powerful efficacy of JANUMET for patients with type 2 diabetes,” said Barry J. Goldstein, vice president, Diabetes and Endocrinology, Merck. “This is important because many patients with type 2 diabetes require treatment with multiple drugs to maintain blood sugar control, and JANUMET XR is a new option to help more patients get to their glucose goals.”

The labeling for JANUMET XR contains a boxed warning for lactic acidosis, a rare, but serious complication that can occur due to metformin accumulation.

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