Alembic Pharma announces Brimonidine Tartrate Ophthalmic Solution USFDA Final Clearance

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• Source: AP


• Date: 31 Mar,2023

Alembic Pharmaceuticals Limited (Alembic) today announced that it 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 Dec 2022 according to IQVIA.

Alembic has a cumulative total of 180 ANDA approvals (156 final approvals and 24 tentative approvals) from USFDA.