The approved product, Ezetimibe and Simvastatin tablets, is a generic version of MSD International’s Vytorin tablets.
New Delhi: Glenmark Pharmaceuticals Friday said 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 product is a generic version of MSD International’s Vytorin tablets.
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.
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.
Headquartered in Mumbai, the company was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer; he named the company after his two sons. The company initially sold its products in India, Russia and Africa. The company went public in India in 1999 and used some of the proceeds to build its first research facility.