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Lupin gets USFDA approval for Bromfenac Ophthalmic Solution

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Lupin said that it has received US Food and Drug Administration (USFDA) approval for its abbreviated new drug application for Bromfenac Ophthalmic Solution to market a drug.
The said drug is equivalent to BromSite Ophthalmic Solution of Sun Pharmaceutical Industries. It will manufactured at Lupins 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.
As per IQVIA MAT December 2023, Bromfenac Ophthalmic Solution 0.075% had estimated annual sales of $15 million in the US.
Meanwhile, the companys board will meet today, 7 February 2024 to consider and take on record the unaudited standalone and consolidated financial results of the company for the quarter and nine-months ended December 31, 2023.
Mumbai-based Lupin is an innovation-led transnational pharmaceutical company. It 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 scrip rose 0.43% to settle at Rs 1,579.75 on Tuesday, 6 February 2024.
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First Published: Feb 07 2024 | 8:29 AM IST

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