Lupin receives USFDA’s approval for Bromfenac Ophthalmic Solution

07 Feb 2024 Evaluate

Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Bromfenac Ophthalmic Solution, 0.075%, to market a generic equivalent of BromSite Ophthalmic Solution, 0.075%, of Sun Pharmaceutical Industries. 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 $15 million in the U.S. (IQVIA MAT December 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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