Global pharma major Lupin Limited on Tuesday 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 percent.
The approval has been granted to market a generic equivalent of BromSite Ophthalmic Solution, 0.075 percent, 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 percent is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.
Bromfenac Ophthalmic Solution 0.075 percent (RLD BromSite) had estimated annual sales of USD 15 million in the U.S. (IQVIA MAT December 2023).
