Global pharma major Lupin Limited on Wednesday 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.
According to the company’s press statement, the approval is 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).
