Lupin bags USFDA approval for Loteprednol Etabonate Ophthalmic Suspension
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 Loteprednol Etabonate Ophthalmic Suspension, 0.5%, to market a generic equivalent to the reference listed drug (RLD)Lotemax Ophthalmic Suspension, 0.5%, of Bausch & Lomb Inc.The product...
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 Loteprednol Etabonate Ophthalmic Suspension, 0.5%, to market a generic equivalent to the reference listed drug (RLD)Lotemax Ophthalmic Suspension, 0.5%, of Bausch & Lomb Inc.
The product will be manufactured at Lupin’s Pithampur facility in India.
Loteprednol Etabonate Ophthalmic Suspension, 0.5%, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis. Seasonal allergic conjunctivitis is a common condition characterized by inflammation of the conjunctiva in response to allergens like pollen. Symptoms include itchy, watery eyes, redness, swelling, and sensitivity to light.
Loteprednol Etabonate Ophthalmic Suspension, 0.5% (RLD Lotemax), had estimated annual sales of USD 59 million in the U.S. (IQVIA MAT February 2024).
Medical Dialogues team had earlier reported that Lupin Limited had launched Bromfenac Ophthalmic Solution, 0.075%. Bromfenac Ophthalmic Solution, 0.075% is a generic equivalent of BromSite Ophthalmic Solution, 0.075%, of Sun Pharmaceutical Industries Limited.
Read also: Lupin unveils Bromfenac Ophthalmic Solution, 0.075% in US
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers.
Read also: Lupin Digital Health's Lyfe Platform gets Class C Medical Device license from CDSCO
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