Global pharma major Lupin Limited 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%.
According to the company’s press statement, the approval is to market a generic equivalent of Bromday Ophthalmic Solution, 0.09%, of Bausch & Lomb Inc. This product will be manufactured at Lupin’s Pithampur facility in India.
Bromfenac Ophthalmic Solution 0.09% (RLD Bromday) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT June 2023).
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