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Merck's Juvisync approved for Type 2 diabetes, high cholesterol

FDA approves first one-pill combination for both conditions

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug that it called the first single-pill combination treatment for Type 2 diabetes and high cholesterol.

The FDA approved Merck's Juvisync (sitagliptin and simvastatin), manufactured by Merck subsidiary MSD International GmbH Clonmel Co., based in Tipperary, Ireland. Merck operates under the name MSD outside the United States and Canada in order to avoid confusion with Germany-based Merck KGaA.

"This is the first product to combine a Type 2 diabetes drug with a cholesterol-lowering drug in one tablet," FDA Division of Metabolism and Endocrinology Products director Mary Parks said. "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."

Of the 26 million Americans with diabetes, about 20 million have Type 2 diabetes and often have high cholesterol levels as well.


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