Impax announced that the Food and Drug Administration (FDA) has granted tentative approval for its Abbreviated New Drug Application (ANDA) for Ezetimibe and Simvastatin Tablets, the generic version of Merck‘s Vytorin.  

Vytorin consists of ezetimibe, a cholesterol absorption inhibitor, and simvastatin, an HMG-CoA reductase inhibitor. It is indicated for use as adjunct to diet in primary hyperlipidemia (heterozygous familial and non-familial) or mixed hyperlipidemia: to reduce elevated total-C, LDL-C, apo B, TG and non-HDL-C, and to increase HDL-C; as adjunct to or when other lipid-lowering treatments for homozygous familial hypercholesterolemia (HoFH) are not available: to reduce elevated total-C and LDL-C.

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The two lipid-lowering compounds work in complementary mechanisms of action. Vytorin reduces elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and increases HDL-C through dual inhibition of cholesterol absorption and synthesis.

Impax plans to gain final FDA approval upon patent and pediatric exclusivity expiration on April 25, 2017. Ezetimibe and Simvastatin Tablets will be available as 10mg/10mg, 10mg/20mg, 10mg/40mg, and 10mg/80mg strengths. 

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