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Lupin gets USFDA’s approval for Metoprolol Succinate Extended-Release Tablets

16 Aug 2023 Evaluate

Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Metoprolol Succinate Extended-Release Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg, to market a generic equivalent of Toprol-XL Tablets, 25 mg, 50 mg, 100 mg and 200 mg of Sequel Therapeutics, LLC. This product will be manufactured at Lupin’s Pithampur facility in India. Metoprolol Succinate Extended-Release Tablets USP (RLD Toprol-XL) had estimated annual sales of $305 million in the U.S. (IQVIA MAT June 2023).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.


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