Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%

Bengaluru, 10 July 2024: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bromfenac Ophthalmic Solution, 0.07%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Prolensa Ophthalmic Solution, 0.07%, of Bausch & Lomb Incorporated (Bausch).

Bromfenac Ophthalmic Solution 0.07% 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. Refer label for a detailed indication.

Bromfenac Ophthalmic Solution, 0.07% has an estimated market size of US$ 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 USFDA.