Lupin bags USFDA nod for Bromfenac Ophthalmic Solution, 0.075%
Bromfenac Ophthalmic Solution, 0.075% is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.
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, 0.075%, to market a generic equivalent of BromSite Ophthalmic Solution, 0.075%, of Sun Pharmaceutical Industries Limited.
Lupin is the exclusive first-to-file for this product, the Company claimed.
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 USD 15 million in the U.S. (IQVIA MAT December 2023).
Medical Dialogues team had earlier reported that the Company had launched Bromfenac Ophthalmic Solution, 0.07%, after having received an approval from the United States Food and Drug Administration (U.S. FDA). Bromfenac Ophthalmic Solution, 0.07% is the generic equivalent of Prolensa Ophthalmic Solution, 0.07%, of Bausch & Lomb Inc.
Read also: Lupin unveils Bromfenac Ophthalmic Solution in US
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. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers.
Read also: Justify proposed dose and rationality: CDSCO Panel Tells Lupin on FDC Sacubitril plus Valsartan
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