|Articles|April 1, 2023

Alembic pharmaceuticals announces USFDA Final Approval for brimonidine tartrate ophthalmic solution 0.15%.

Brimonidine Tartrate Ophthalmic Solution is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma.

Alembic Pharmaceuticals Limited (Alembic) announced 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%.

According to a press release from the company, the approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD), Alphagan P Ophthalmic Solution, 0.15%, of AbbVie Inc.

The drug is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

According to the company, Alembic has a cumulative total of 180 ANDA approvals (156 final approvals and 24 tentative approvals) from USFDA.

Alembic, headquartered in India, is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world and conducts vertically integrated research and development.

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Alembic pharmaceuticals announces USFDA Final Approval for brimonidine tartrate ophthalmic solution 0.15%.

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