Alembic Pharmaceuticals announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bromfenac Ophthalmic Solution, 0.07 per cent.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Prolensa Ophthalmic Solution, 0.07 per cent, of Bausch & Lomb. 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.
Bromfenac Ophthalmic Solution, 0.07 per cent has an estimated market size of $ 168 million for twelve months ending March 2024 according to IQVIA. Alembic has a cumulative total of 207 ANDA approvals (180 final approvals and 27 tentative approvals) from the US FDA.