Lupin secures USFDA tentative nod for Brimonidine Tartrate Ophthalmic Solution
Mumbai: Global pharma major Lupin Limited has announced that the Company has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC), to market a generic equivalent of Lumify Ophthalmic Solution, 0.025%, of Bausch & Lomb Incorporated. This product will be manufactured at Lupin’s Pithampur facility in India.
Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) is indicated to relieve redness of the eye due to minor eye irritations.
Brimonidine Tartrate Ophthalmic Solution (RLD Lumify) had an estimated annual sale of USD 39 million in the U.S. (IQVIA MAT June 2024).
Read also: Lupin Announces Positive Results from Global Phase 3 Trial of Lucentis Biosimilar
Medical Dialogues team had earlier reported that the Company had received approval from the U.S. FDA for its ANDA for Prednisolone Acetate Ophthalmic Suspension USP, 1% to market a generic equivalent of Pred Forte Ophthalmic Suspension, 1%, of AbbVie Inc
Read also: Lupin bags USFDA nod for Prednisolone Acetate Ophthalmic Suspension
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. Trusted by healthcare professionals and consumers globally, the company specializes 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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