Alembic Pharmaceuticals gets USFDA nod for ophthalmic solution
The approved product is therapeutically equivalent to the reference listed drug (RLD), Bromday Ophthalmic Solution, 0.09 percent, of Bausch & Lomb. Drug firm Alembic Pharmaceuticals on June 24 said it has received approval from the US health regulator for Bromfenac Ophthalmic Solution, used for 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 percent, of Bausch & Lomb.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Bromfenac Ophthalmic Solution 0.09 percent, Alembic Pharmaceuticals said in a filing to BSE.
Quoting IQVIA data, Alembic Pharma said Bromfenac Ophthalmic Solution 0.09 percent 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 USFDA, it added.
Shares of Alembic Pharmaceuticals were trading 1.62 percent higher at Rs 483.60 a piece.
Source : moneycontrol