Lupin gets USFDA’s approval for Bromfenac Ophthalmic Solution

23 Nov 2023 Evaluate

Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Bromfenac Ophthalmic Solution, 0.07%, 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% 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 $185 million in the U.S. (IQVIA MAT September 2023). 

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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