USFDA approves Lupin Bromfenac Ophthalmic Solution

Mumbai: Global pharma major Lupin Limited has announced that the Company 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%, 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.

According to WHO, Cataract is a clouding of the lens in the eye that normally affects vision. Cataract, the most common cause of blindness and visual impairment, is often related to ageing. Occasionally children are born with the condition, or a cataract may develop following an eye injury, or as a result of inflammation or other diseases, such glaucoma and diabetes. 

Bromfenac Ophthalmic Solution (RLD Prolensa) had estimated annual sales of USD 185 million in the U.S. (IQVIA MAT September 2023).

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Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers.

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