Alembic Pharmaceuticals Limited (Alembic) announced today that it has received final FDA approval for its Abbreviated New Drug Application (ANDA) Brimonidine Tartrate Ophthalmic Solution, 0.15%. The ANDA is therapeutically equivalent to AbbVie Inc.’s reference listed drug product (RLD), Alphagan P Ophthalmic Solution, 0.15%. Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist used to treat open-angle glaucoma or ocular hypertension by lowering intraocular pressure (IOP).
According to IQVIA, Brimonidine Tartrate Ophthalmic Solution, 0.15% has a market value of US$ 97 million for the twelve months ending December 2022. Alembic has received 180 ANDA approvals from the USFDA (156 final approvals and 24 tentative approvals).