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Lupin Receives approval from USFDA for Metoprolol Succinate Extended-Release Tablets USP

 

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Lupin Receives approval from USFDA for Metoprolol Succinate Extended-Release Tablets USP

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Lupin Limited announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) 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 USD 305 million in the U.S. (IQVIA MAT June 2023).