Lupin gets USFDA nod for Bromfenac Ophthalmic Solution

Pharma major Lupin on Wednesday said it has received approval from the US health regulator to market its generic Bromfenac Ophthalmic Solution used to treat post-operative inflammation in patients who have undergone cataract surgery. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Bromfenac Ophthalmic Solution 0.09 per cent, Lupin said in a regulatory filing.

The product is the generic equivalent of Bromday Ophthalmic Solution 0.09 per cent of Bausch + Lomb, it added.

The product will be manufactured at Lupin's Pithampur facility in Madhya Pradesh, the company said.


Bromfenac Ophthalmic Solution 0.09 per cent had estimated annual sales worth USD 11 million in the US, Lupin said, citing IQVIA MAT data for June.