Lupin Receives FDA Approval for Generic Bromday Equivalent
08/17/2023
India-based Lupin announced that it has received approval from the FDA for its abbreviated new drug application for bromfenac ophthalmic solution 0.09% for the treatment of postoperative inflammation and pain.
The product is a generic equivalent of Bromday (Bausch & Lomb), which had estimated annual sales of $11 million in the US. (IQVIA MAT June 2023).
The generic bromfenac product will be manufactured at Lupin’s Pithampur facility in India.
In June, India-based Alembic Pharmaceuticals received FDA approval for its version of bromfenac ophthalmic solution 0.09%, also a generic equivalent to Bromday.