The approved product is therapeutically equivalent to the reference listed drug (RLD), Bromday Ophthalmic Solution, 0.09 per cent, of Bausch & Lomb
Alembic Pharmaceuticals announced that it has received approval from the US health regulator for Bromfenac Ophthalmic Solution, used for the treatment of post-operative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
The approved product is therapeutically equivalent to the reference listed drug (RLD), Bromday Ophthalmic Solution, 0.09 per cent, of Bausch & Lomb.
The company has received approval from the US Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) Bromfenac Ophthalmic Solution 0.09 per cent, Alembic Pharmaceuticals said in a filing to BSE. Quoting IQVIA data, Alembic Pharma said Bromfenac Ophthalmic Solution 0.09 per cent has an estimated market size of USD 6 million for 12 months ending December 2018.
The company currently has a total of 96 ANDA approvals (84 final approvals and 12 tentative approvals) from US FDA, it added.
Shares of Alembic Pharmaceuticals were trading 1.62 per cent higher at Rs 483.60 apiece.