Global pharma major Lupin Limited (Lupin)announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for bromfenac ophthalmic aolution, 0.075%, to market a generic equivalent of BromSite ophthalmic aolution, 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 aolution, 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).