Global pharma major Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for brimonidine tartrate ophthalmic solution, 0.025% (OTC), to market a generic equivalent of Lumify ophthalmic solution, 0.025%, of Bausch & Lomb Incorporated.
This product will be manufactured at Lupin’s Pithampur facility in India.
Brimonidine tartrate ophthalmic solution, 0.025%(OTC) is indicated to relieve redness of the eye due to minor eye irritations.
Brimonidine tartrate ophthalmic solution (RLD Lumify) had an estimated annual sale of $39million in the U.S. (IQVIA MAT June2024).