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, as per an exchange filling.
Alembic Pharmaceuticals announced in a statement that the business has acquired final US Food & Drug Administration (USFDA) approval to market Brimonidine Tartrate Ophthalmic Solution.
Alphagan P Ophthalmic Solution from AbbVie Inc. is therapeutically equal to the approved product.
An alpha adrenergic receptor agonist called brimonidine tartrate ophthalmic solution is approved to lower increased intraocular pressure (IOP) in people 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.
Alembic has a cumulative total of 180 ANDA approvals (156 final approvals and 24 tentative approvals) from USFDA.
