FDA Approves New Combination Drug, Juvisync, for Treatment of Type 2 Diabetes

October 08, 2011

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The FDA has approved a new treatment for type 2 diabetes that combines the glucose-lowering medication sitagliptin, the active component of JANUVIA, with the cholesterol-lowering medication ZOCOR (simvastatin). The new drug, produced by Merck, known as MSD outside the United States and Canada, will be marketed under the brand name JUVISYNC™. JUVISYNC is the first treatment option for healthcare providers to help patients who need the blood sugar-lowering benefits of a DPP-4 inhibitor and the cholesterol-lowering benefits of simvastatin, with the convenience of a single tablet once daily.
The FDA approved JUVISYNC based upon clinical bioequivalence studies in healthy subjects that demonstrated administration of JUVISYNC is equivalent to co-administration of corresponding doses of the two individual medications, sitagliptin and simvastatin, as separate tablets.
JUVISYNC should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. 

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