Lupin receives approval from U.S. FDA for Loteprednol Etabonate Ophthalmic Gel

Global pharma major Lupin Limited (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).

Shares of Lupin Limited was last trading in BSE at Rs. 1937.80 as compared to the previous close of Rs. 1936.90. The total number of shares traded during the day was 10740 in over 1103 trades.

The stock hit an intraday high of Rs. 1955.35 and intraday low of 1925.50. The net turnover during the day was Rs. 20848034.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Pharmaceuticals USFDA Approval ANDA LoteprednolEtabonateOphthalmicGel