Glenmark Pharmaceuticals on Tuesday said it had received final approval from the US health regulator for generic version of AstraZeneca’s Nexium, used to treat acid reflux.
Glenmark Pharmaceuticals Inc, USA, has been granted final approval by the United States Food & Drug Administration (USFDA) for Esomeprazole Magnesium delayed-release capsules USP in the strengths of 20 mg and 40 mg, the company said in a BSE filing.
The approved product is a generic version of AstraZeneca Pharmaceuticals’ Nexium delayed-release capsules.
Citing IQVIA sales data, Glenmark said, Nexium delayed-release capsules, 20 mg and 40 mg achieved annual sales of around USD 395.1 million in the 12-month period ended March 2019.
The company said its current portfolio consists of 153 products authorised for distribution in the US and 58 ANDA’s pending approval with the USFDA. – The Tribune