By: IPP Bureau
Last updated : March 31, 2023 9:14 am
Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure
Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brimonidine Tartrate Ophthalmic Solution, 0.15%.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Alphagan P Ophthalmic Solution, 0.15%, of AbbVie Inc. 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.
Brimonidine Tartrate Ophthalmic Solution, 0.15% has an estimated market size of US $97 million for twelve months ending December 2022 according to IQVIA.
Alembic has a cumulative total of 180 ANDA approvals (156 final approvals and 24 tentative approvals) from USFDA.