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07 Feb 2024
Admin
News Article

Lupin receives US FDA approval

Lupin receives US FDA approval for bromfenac ophthalmic solution, 0.075%

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (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. 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.

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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.