Lupin gets USFDA approval for generic equivalent of Toprol XL Tablets
This product will be manufactured at Lupin's Pithampur facility in India.;
Mumbai: Global pharma major Lupin Limited today announced that the company 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.
The product is 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).
Medical Dialogues team had earlier reported that Lupin had received approval from the U.S. FDA for its Abbreviated New Drug Application for Doxycycline Hyclate Delayed-Release Tablets USP, 50 mg, 60 mg, 75 mg, 80 mg, 100 mg, 120 mg, 150 mg, and 200 mg.
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