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Lupin receives US FDA approval for loteprednol etabonate ophthalmic gel

03 Jul 2025
Admin
News Article

Lupin receives US FDA approval for loteprednol etabonate ophthalmic gel

Overview

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for loteprednol etabonate ophthalmic gel, 0.38%. Loteprednol etabonate ophthalmic gel, 0.38% is bioequivalent to Lotemax SM ophthalmic gel of Bausch & Lomb Inc. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. This product will be manufactured at Lupin’s Pithampur facility in India.

Loteprednol etabonate: Indication

Loteprednol etabonate ophthalmic gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.