- Pharma
- 1 min read
Glenmark Pharma gets USFDA nod for cholesterol-lowering drug
The approval has been granted by the United States Food and Drug Administration (USFDA) 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.
The approved product is a generic version of MSD International's Vytorin tablets.
The approval has been granted by the the United States Food and Drug Administration (USFDA) 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-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 BSE.
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