Alembic Pharma gets USFDA's final approval for Brimonidine Tartrate Ophthalmic Solution

30 Mar 2023 Evaluate

Alembic Pharmaceuticals 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 $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.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

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