Glenmark: USFDA gives nod to cholesterol regulating drugs

Leading pharmaceutical company's US arms has received final approval for Ezetimibe and Simvastatin Tablets. The medication is used to treat high levels of cholesterol in the blood.

The combination drug is a generic version of Vytorin tablets of MSD International GmbH. The United States Food & Drug Administration (USFDA) has granted Glenmark Pharmaceuticals Inc., USA ANDA approval for Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg. The drug is prescribed for the reduction of high levels of total cholesterol as an adjunct to proper diet. Ezetimibe is a selective inhibitor of intestinal cholesterol and related phytosterol absorption, while simvastatin, is an HMG-CoA reductase inhibitor or statin.

Vytorin Tablets registered an annual sales of approximately US$92.4 million in the US market, as per IQVIATM sales data until April 2019.

Glenmark's product pipeline consists of 157 products authorised for distribution in the US market and 58 ANDAs pending approval with the USFDA.

On Friday, the stock of Glenmark Pharmaceuticals was trading at Rs. 449.70 per share, up by 0.30 per cent at 12:01 hours on BSE.