Lupin secures FDA nod for generic Bromday Ophthalmic Solution

Global pharmaceutical titan, Lupin Limited, has officially declared its success in securing the esteemed approval from the United States Food and Drug Administration (FDA). This sanction is specific to Lupin’s Abbreviated New Drug Application (ANDA) for Bromfenac Ophthalmic Solution at a concentration of 0.09%. With this, Lupin is now green-lighted to market its version as the generic alternative to the Bromday Ophthalmic Solution, 0.09%, a renowned product of Bausch & Lomb Inc.

The market traction for Bromfenac Ophthalmic Solution 0.09% (equivalent to Reference Listed Drug Bromday) has been strong, with annual sales recorded at a significant $11 million in the U.S. territory, as per IQVIA MAT data till June 2023.

The manufacturing prowess for this approved ophthalmic solution will be showcased at Lupin’s cutting-edge Pithampur facility located in India. This advancement accentuates Lupin’s drive to expand its product portfolio and fortify its standing in the U.S. generic pharmaceutical domain.