USFDA nod to Lupin Brimonidine Tartrate Ophthalmic Solution
Brimonidine Tartrate Ophthalmic Solution, 0.1% indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma.
Mumbai: Global pharma major Lupin Limited has announced that the Company 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%.
The product is a generic equivalent of Alphagan P Ophthalmic Solution, 0.1%, of AbbVie Inc. It 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.
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Open-Angle Glaucoma is the most common form of glaucoma, a group of eye conditions that damage the optic nerve, leading to vision loss. This damage is often caused by abnormally high pressure in the eye (intraocular pressure), though normal-pressure glaucoma can also occur.
Medical Dialogues team had earlier reported that Lupin Limited had received USFDA nod for its Abbreviated New Drug Application for Travoprost Ophthalmic Solution USP, 0.004%(Ionic Buffered Solution). Travoprost Ophthalmic Solution USP, 0.004%, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
Read also: Lupin bags USFDA nod for Travoprost Ophthalmic Solution
Brimonidine Tartrate Ophthalmic Solution (RLD Alphagan P) had an estimated annual sales of USD178.5 million in the U.S. (IQVIA MAT June 2024).
Lupin Limited is a global pharmaceutical Company 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. The company has a presence in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.
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