Generic Drug Maker Alembic Pharmaceuticals Receives FDA Approval for Bromfenac Ophthalmic Solution 0.09%
06/24/2019
India-based Alembic Pharmaceuticals announced that the company has received FDA approval for its abbreviated new drug application (NDA) for bromfenac ophthalmic solution 0.09% for the treatment of postoperative inflammation and pain.
The approved NDA is therapeutically equivalent to the reference listed drug, Bromday Ophthalmic Solution, 0.09% (Bausch + Lomb).
Bromfenac Ophthalmic Solution 0.09% has an estimated market size of $ 6 million for 12 months ending December 2018, according to market research company IQVIA.
Alembic now has of 96 abbreviated NDA approvals (84 final approvals and 12 tentative approvals) from the FDA.