Lupin bags USFDA tentative nod for Olopatadine Hydrochloride Ophthalmic Solution(OTC)
Mumbai: Global pharma major Lupin Limited has announced that it has received a tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC), to market a generic equivalent of Pataday Once Daily Relief, 0.7% (OTC), of Alcon Laboratories Inc.
This product will be manufactured at Lupin’s Pithampur facility in India.
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% is indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Olopatadine Hydrochloride Ophthalmic Solution USP (RLD Pataday) had an estimated annual sale of USD22 million in the U.S. (IQVIA MAT April 2024).
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 specialises 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 7.8% of its revenue in research and development in FY24.
Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally.
