Pharma major Lupin Ltd on Wednesday said it has received approval from the US health regulator to market its generic Metoprolol Succinate extended-release tablets used for lowering blood pressure.
The approval by the US Food and Drug Administration (USFDA) for the abbreviated new drug application is for Metoprolol Succinate extended-release tablets of strengths 25 mg, 50 mg, 100 mg, and 200 mg, Lupin said in a regulatory filing.
These are generic equivalent of Toprol-XL Tablets of Sequel Therapeutics, LLC.
This product will be manufactured at Lupin's Pithampur facility in India, the company said.
Metoprolol Succinate extended-release tablets had an estimated annual sales of USD 305 million in the US, the company said citing IQVIA MAT June 2023 data.
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