Lupin Receives Approval From U.S. FDA For Bromfenac Ophthalmic Solution

Global pharma major Lupin Limited (Lupin) on Wednesday announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Bromfenac Ophthalmic Solution, 0.09 percent, to market a generic equivalent of Bromday Ophthalmic Solution, 0.09 percent, of Bausch & Lomb Inc, the company announced through an exchange filing.

This product will be manufactured at Lupin’s Pithampur facility in India.

Bromfenac Ophthalmic Solution 0.09 percent (RLD Bromday) had estimated annual sales of USD 11 million in the U.S.

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The shares of Lupin on Wednesday at 2:33 pm IST were at Rs 1,100.75, up by 1.74 percent.

About Lupin

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.