Lupin Receives Approval from U.S. FDA for Loteprednol Etabonate Ophthalmic Gel

Global pharma major Lupin Limited has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Gel, 0.38%. This product will be manufactured at Lupin’s Pithampur facility in India and is indicated for the treatment of postoperative inflammation and pain following ocular surgery. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. Loteprednol Etabonate Ophthalmic Gel, 0.38% (RLD Lotemax® SM) had an estimated annual sale of USD 29 million in the U.S. (IQVIA MAT May 2025).