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Lupin Receives US FDA Approval for Generic Alphagan P Ophthalmic Solution, 0.1%

29 Aug 2024
Admin
News Article

Lupin Receives US FDA Approval for Generic Alphagan P Ophthalmic Solution, 0.1%

Overview

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for brimonidine tartrate ophthalmic solution, 0.1%, to market a generic equivalent of Alphagan P ophthalmic solution, 0.1%, of AbbVie Inc. This product will be manufactured at Lupin’s Pithampur facility in India.

Brimonidine Tartrate Ophthalmic Solution

Indication- Brimonidine tartrate ophthalmic solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Annual sale- Brimonidine tartrate ophthalmic solution (Alphagan P) had an estimated annual sales of USD 178.5 million in the US (IQVIA MAT June 2024).

About Lupin Limited

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets.
Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.