Diabetes :: FDA Approves Janumet for Type 2 Diabetes

Janumet (sitagliptin/metformin HCl) provides significantly greater A1C1 reduction than metformin alone and helped more than twice as many patients get to A1C goal.

Merck & Co., Inc. announced that the U.S. Food and Drug Administration (FDA) approved JANUMET?, the first and only tablet combining a dipeptidyl peptidase-4 (DPP-4) inhibitor, sitagliptin (also known as JANUVIA?), and metformin for the treatment of type 2 diabetes.

JANUMET has been approved, as an adjunct to diet and exercise, to improve blood sugar (glucose) control in adult patients with type 2 diabetes who are not adequately controlled on metformin or sitagliptin alone, or in patients already being treated with the combination of sitagliptin and metformin. JANUMET should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

The FDA approved JANUMET based upon clinical data including sitagliptin plus metformin as separate tablets. A clinical bioequivalence study has demonstrated the equivalence between JANUMET and sitagliptin plus metformin as separate tablets.

“JANUMET is the latest advance in Merck’s longstanding commitment to developing effective medicines for type 2 diabetes,” said Adam Schechter, president, United States Human Health, Merck & Co., Inc. “With JANUMET and JANUVIA, Merck now has a growing family of products that provides physicians with important treatment options for patients with type 2 diabetes.”


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