Lupin Limited  announced that it 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).