lunes, 10 de octubre de 2011

The FDA announced approval of sitagliptin/simvastatin

The FDA announced Friday approval of Merck & Co.'s Juvisync (sitagliptin/simvastatin), making it the first combination drug authorised to treat type 2 diabetes and hypercholesterolemia in one tablet. The product combines the company's DPP-4 inhibitor Januvia (sitagliptin) with its statin Zocor (simvastatin).

The agency noted that the fixed-dose combination product is based on "substantial experience" with both individual drugs, and the ability of the single tablet to deliver similar amounts of the compounds to the bloodstream as when they are dosed separately. Mary H. Parks, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, remarked that "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."


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