Thursday, 12 December 2019

Glenmark receives ANDA approval for Ezetimibe and Simvastatin Tablets

28 June 2019 | News

It is a generic version of Vytorin Tablets

Glenmark Pharmaceuticals has been granted final approval by the USFDA for Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, a generic version of Vytorin Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, of MSD International GmbH.

According to IQVIATM sales data for the 12 month period ending April 2019, the Vytorin® Tablets market2 achieved annual sales of approximately $92.4 million.

Glenmark’s current portfolio consists of 157 products authorized for distribution in the U.S. marketplace and 58 ANDA’s pending approval with the USFDA.

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