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Lupin Receives FDA Approval for Bromfenac Ophthalmic Solution, 0.09%

Lupin Receives FDA Approval for Bromfenac Ophthalmic Solution, 0.09%

August 16, 2023

Lupin Limited, a global pharmaceutical company, has officially received approval from the US FDA for its Abbreviated New Drug Application for Bromfenac Ophthalmic Solution, 0.09%.

This approval allows Lupin to introduce a generic counterpart to Bausch & Lomb Inc.'s Bromday Ophthalmic Solution, 0.09%. The manufacturing of this product will take place at Lupin’s Pithampur facility located in India.

Bromfenac Ophthalmic Solution 0.09%, also known as the Reference Listed Drug (RLD Bromday), achieved approximately USD 11 million in annual sales within the U.S. market (according to IQVIA MAT June 2023).

Bromfenac Ophthalmic Solution 0.09% is a specific concentration of Bromfenac eye drops that is commonly used to treat inflammation and pain in the eyes following cataract surgery or other eye surgeries. It is part of the nonsteroidal anti-inflammatory drug (NSAID) class and is designed to reduce inflammation and provide relief from discomfort in the eye.

About Lupin

Lupin, an innovative multinational pharmaceutical corporation headquartered in Mumbai, India, specializes in the development and distribution of a diverse array of branded and generic formulations, APIs, and biotechnology products. Operating across more than 100 markets, including the U.S., India, South Africa, Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East, the company boasts a robust global presence.

Lupin holds a prominent position in sectors such as cardiovascular, anti-diabetic, and respiratory care. It also maintains a strong foothold in therapeutic areas such as anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health. Impressively, Lupin ranks as the third-largest pharmaceutical company in the U.S. in terms of prescriptions. Demonstrating its commitment to advancement, the company allocated 7.9% of its revenue to research and development during the fiscal year 2023.