Lupin Receives Approval From U.S. FDA For Metoprolol Succinate Extended-Release Tablets USP

Global pharma major Lupin Limited (Lupin) 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, to market a generic equivalent of Toprol-XL® Tablets, 25 mg, 50 mg, 100 mg and 200 mg of Sequel Therapeutics, LLC, the company announced through an exchange filing.

The 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.

Lupin Limited shares

The shares of Lupin on Wednesday at 3:30pm were at Rs 1,113.50, up by 2.91 percent.