Alembic Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (U.S. FDA) for its abbreviated new drug application for Brimonidine Tartrate Ophthalmic Solution, 0.15%.
The approved ANDA is therapeutically equivalent to the reference listed drug product, Alphagan P Ophthalmic Solution, 0.15%, of AbbVie Inc. An alpha adrenergic receptor agonist, the drug is indicated for reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, Lupin said on Thursday.
The estimated market size of Brimonidine Tartrate Ophthalmic Solution, 0.15% for the 12 months ending Dec. 2022 was $97 million, the company said, citing IQVIA numbers.
Alembic said it has a total of 180 ANDA approvals (156 final approvals and 24 tentative approvals) from the U.S. FDA.
