Glenmark Pharma: Acid reflux capsules get US FDA nod
Glenmark Pharmaceuticals on Tuesday said it has 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 (US FDA) 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 products 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 $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 Abbreviated New Drug Applications (ANDA) pending approval with the US FDA.