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FDA approves extended-release tablets for type 2 diabetes


FDA approved sitagliptin and metformin hydrochloride (HCl) extended-release (Janumet XR, Merck) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of Januvia (sitagliptin), with extended-release metformin.

FDA has approved Janumet XR tablets (Merck), a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of Januvia, 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.

The drug 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 the tablets.

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 2 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," Barry J. Goldstein, MD, PhD, vice president, Diabetes and Endocrinology, Merck, said in a company press release. "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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