Article

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.

an image of the FDA logo on a grey background.

(Image Credit: AdobeStock)

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.

Newsletter

Don’t miss out—get Ophthalmology Times updates on the latest clinical advancements and expert interviews, straight to your inbox.

Related Videos
(Image credit: Ophthalmology Times) Inside ASCRS 2025: Francis S. Mah, MD, takes the helm with a vision for research, education, and advocacy
(Image credit: Ophthalmology Times) Neda Shamie_Controversies in Modern Eye Care 2025
(Image credit: Ophthalmology Times) AGS 2025: A look at Gemini and the MIGS revolution with Mona Kaleem, MD
(Image credit: Ophthalmology Times) AGS 2025: Development and evaluation of an AI model to set target IOP with Jithin Yohannan, MD, MPH
(Image credit: Ophthalmology Times) AGS 2025: Achieving success as an academic ophthalmologist with Thomas V. Johnson III, MD, PhD
(Image credit: Ophthalmology Times) AGS 2025: Constance Okeke, MD, highlights 1-year Streamline canaloplasty outcomes
© 2025 MJH Life Sciences

All rights reserved.