The United States Food and Drug Administration (USFDA) has given its approval to Glenmark Pharmaceuticals for Ezetimibe and Simvastatin tablets. These are meant for treating high levels of cholesterol in the blood.
The drugmaker Glenmark Pharmaceuticals on Friday said it has received final approval from the US health regulator for these tablets.
The approved product is a generic version of MSD International’s Vytorin tablets.
The approval has been given for the two 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-month period 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 USFDA.
Shares of Glenmark Pharma were trading 0.55 per cent higher at Rs 450.80 apiece on Bombay Stock Exchange.
(With inputs from PTI)