Global pharma major Lupin Limited on Friday 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, 0.07%.
According to a press statement, the approval has been granted to market a generic equivalent of Prolensa Ophthalmic Solution, 0.07%, of Bausch & Lomb Inc.
Lupin is the exclusive first-to-file for this product and is eligible for 180-day exclusivity. The product will be manufactured at Lupin’s Pithampur facility in India.
Bromfenac Ophthalmic Solution, 0.07 percent is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
Bromfenac Ophthalmic Solution (RLD Prolensa) had estimated annual sales of USD 185 million in the U.S. (IQVIA MAT September 2023).