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FDA approves combination sitagliptin, simvastatin
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The FDA today announced approval of a fixed-dose combination therapy containing sitagliptin and simvastatin for the treatment of adults with type 2 diabetes and high cholesterol.
“This is the first product to combine a type 2 diabetes drug with a cholesterol-lowering drug in one tablet,” Mary H. Park, MD, director of the division of metabolism and endocrinology products in the FDA Center for Drug Evaluation and Research, said in a 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 combination tablet (Juvisync; Merck) was approved in sitagliptin/simvastatin dosage strengths of 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg. According to the FDA, treatment should only be prescribed when patients require treatment with both sitagliptin (Januvia, Merck) and simvastatin (Zocor, Merck).
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