Lupin gets US FDA nod for Bromfenac Ophthalmic Solution, 0.09%; Metoprolol Succinate ER Tablets USP

Lupin has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Bromfenac Ophthalmic Solution, 0.09%, to market a generic equivalent of Bromday Ophthalmic Solution, 0.09%, of Bausch & Lomb Inc. This product will be manufactured at Lupin’s Pithampur facility in India.

Bromfenac Ophthalmic Solution 0.09% (RLD Bromday) had estimated annual sales of $11 million in the US (IQVIA MAT June 2023).

It has also received approval from the USFDA 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.

Metoprolol Succinate Extended-Release Tablets USP (RLD Toprol-XL) had estimated annual sales of USD 305 million in the US (IQVIA MAT June 2023).

Both products will be manufactured at Lupin’s Pithampur facility in India.