NEW DELHI: Alembic Pharmaceuticals Ltd on Tuesday said it has received final approval from the US health regulator for its generic Bromfenac ophthalmic solution, which is indicated for the treatment of postoperative inflammation and pain in patients who have undergone cataract surgery. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Bromfenac Ophthalmic Solution, 0.07 per cent, Alembic Pharmaceuticals said in a regulatory filing.
The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Prolensa Ophthalmic Solution, 0.07 per cent of Bausch & Lomb Incorporated (Bausch), it added.
Bromfenac Ophthalmic Solution 0.07 per cent is a Nonsteroidal Anti-inflammatory Drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery, the company said.
It has an estimated market size of USD 168 million for 12 months ended March 2024, Alembic said citing IQVIA data.
