Alembic Pharma gets USFDA nod for generic ophthalmic solution

Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator to market a generic product, used to treat high fluid pressure in the eye, in the US market.

The company has received final approval from the US Food & Drug Administration (USFDA) to market Brimonidine Tartrate Ophthalmic Solution, Alembic Pharmaceuticals said in a statement.

The approved product is therapeutically equivalent to AbbVie Inc's Alphagan P Ophthalmic Solution.

Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

According to IQVIA, Brimonidine Tartrate Ophthalmic Solution has an estimated market size of USD 97 million for twelve months ending December 2022.