Pharma major Lupin Limited on Wednesday announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Brimonidine Tartrate Ophthalmic Solution, 0.1%.
According to the company’s statement, the approval has been granted 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, 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.
Brimonidine Tartrate Ophthalmic Solution (RLD AlphaganP) had an estimated annual sales of USD178.5 million in the U.S. (IQVIA MAT June 2024).
