Lupin's Metoprolol succinate tablets granted USFDA approval

Mumbai: Lupin Limited, announced today that the United States Food and Drug Administration (USFDA) has granted approval for its Abbreviated New Drug Application (ANDA) for Metoprolol Succinate extended- release tablets USP.

These tablets are available in strengths of 25 mg, 50 mg, 100 mg, and 200 mg, and they are intended to serve as a generic version of Toprol-XL® Tablets by Sequel Therapeutics, LLC. The manufacturing of this product will take place at Lupin's facility in Pithampur, India.

The original Metoprolol Succinate Extended-Release Tablets USP (known as RLD Toprol-XL®) were estimated to achieve annual sales of approximately USD 305 million in the U.S. as of June 2023, according to IQVIA data