Alembic Pharmaceuticals Ltd on 9 July announced receiving approval from the US Food and Drug Administration (USFDA) for its Bromfenac ophthalmic solution that is used to treat postoperative inflammation and pain in patients who have undergone cataract surgery.

Alembic Pharmaceuticals announced in a regulatory filing that the US Food & Drug Administration (USFDA) has approved their abbreviated new drug application (ANDA) for Bromfenac Ophthalmic Solution, 0.07 per cent. 

This approved abbreviated new drug application (ANDA) is therapeutically equivalent to the Reference Listed Drug (RLD) Prolensa Ophthalmic Solution, 0.07 per cent by Bausch & Lomb Incorporated (Bausch).

Bromfenac Ophthalmic Solution 0.07 per cent is a Nonsteroidal Anti-inflammatory Drug (NSAID) used to treat postoperative inflammation and reduce ocular pain in patients who have undergone cataract surgery. 

According to IQVIA data, the drug has an estimated market size of USD 168 million for the 12 months ending March 2024.