Glenmark Pharma gets US FDA nod for cholesterol lowering drug

The approved products, Ezetimibe and Simvastatin tablets in the strengths of 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, is a generic version of MSD International’s Vytorin tablets

Glenmark Pharmaceuticals announced that it has received final approval from the US health regulator for Ezetimibe and Simvastatin tablets, used for treating high levels of cholesterol in the blood.

The approved products are generic versions of MSD International’s Vytorin tablets. The approval has been granted by the United States Food and Drug Administration (US FDA) for Ezetimibe and Simvastatin tablets in the strengths of 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, the company said in a statement.

Citing IQVIA sales data, Glenmark said Vytorin tablets’ market achieved annual sales of approximately USD 92.4 million for the 12 months ended April 2019.

The company said its current portfolio consists of 157 products authorised for distribution in the US and 58 ANDAs pending approval with the US FDA.

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