Lupin bags USFDA nod 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, 0.2%, to market
a generic equivalent to the reference listed drug (RLD) Alrex Ophthalmic Suspension, 0.2%, of Bausch
& Lomb Inc.
The product will be manufactured at Lupin’s Pithampur facility in India.
Loteprednol Etabonate Ophthalmic Suspension, 0.2%, is indicated for the temporary relief of the signs
and symptoms of seasonal allergic conjunctivitis.
Loteprednol Etabonate Ophthalmic Suspension, 0.2% (RLD Alrex), had estimated annual sales of USD
29.1 million in the U.S. (IQVIA MAT October 2023).
Read also: Lupin to buy established products portfolio in Europe, Canada from Sanofi for Rs 91 crore
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.
