Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Gel

Lupin today 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 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 Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.

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).

 

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