Mumbai: Lupine Limited announced that it has received approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Loteprednol Etabonate Ophthalmic Suspension0.2 per cent, to market a generic equivalent to the reference listed drug (RLD, Alrex Ophthalmic Suspension0.2 per cent, of Bausch & Lomb Inc. The product will be manufactured at Lupin’s Pithampur facility in India.
Loteprednol Etabonate Ophthalmic Suspension, 0.2 per cent, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.
Loteprednol Etabonate Ophthalmic Suspension, 0.2 per cent (RLD Alrex), had estimated annual sales of $29.1 million in the US (IQVIA MAT October 2023).
