Lupin Receives Approval From U.S. FDA For Bromfenac Ophthalmic Solution, 0.075%

Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Bromfenac Ophthalmic Solution, 0.075%, to market a generic equivalent of BromSite Ophthalmic Solution, 0.075%, of Sun Pharmaceutical Industries Limited. Lupin is the exclusive first-to-file for this product. This product will be manufactured at Lupin’s Pithampur facility in India.

Bromfenac Ophthalmic Solution, 0.075% is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.

Bromfenac Ophthalmic Solution 0.075% (RLD BromSite) had estimated annual sales of USD 15 million in the U.S. (IQVIA MAT December 2023).