October 7th, 2011

FDA Approves Juvisync, Combination of Sitagliptin and Simvastatin

The FDA has approved a fixed-dose combination tablet consisting of sitagliptin and simvastatin, two drugs previously approved for type 2 diabetes and hypercholesterolemia. Merck will market the new drug as Juvisync.

“This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet,” said Mary H. Parks, the director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, in an FDA press release. “However, to ensure safe and effective use of this product, tablets containing different doses of sitagliptin and simvastatin in fixed-dose combination have been developed to meet the different needs of individual patients. Dose selection should factor in what other drugs the patient is taking.”

The FDA said it had approved dosage strengths for sitagliptin/simvastatin of 100 mg/10 mg, 100 mg/20 mg, and 100 mg/40 mg. Other dosage combinations are under development.

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