Alembic Pharma gets USFDA nod for Bromfenac Ophthalmic Solution

The approved product, Bromfenac Ophthalmic Solution is therapeutically equivalent to the reference listed drug (RLD), Bromday Ophthalmic Solution, 0.09 per cent, of Bausch & Lomb.

New Delhi: Drug firm Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator for Bromfenac Ophthalmic Solution, used for the treatment of postoperative 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 (USFDA) for its abbreviated new drug application (ANDA) Bromfenac Ophthalmic Solution 0.09 per cent, Alembic Pharmaceuticals said in a filing to BSE.

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Quoting IQVIA data, Alembic Pharma said Bromfenac Ophthalmic Solution 0.09 per cent has an estimated market size of $ 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.

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