Global pharmaceutical leader Lupin (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Loteprednol Etabonate Ophthalmic Gel, 0.38 per cent. This approval allows Lupin to market a generic equivalent of Lotemax SM Ophthalmic Gel by Bausch & Lomb Inc.
Lupin is the exclusive first-to-file applicant for this product and may qualify for a 180-day market exclusivity. The gel will be manufactured at Lupin’s state-of-the-art facility in Pithampur, India.
Loteprednol Etabonate Ophthalmic Gel, 0.38 per cent is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. Its reference product, Lotemax SM, recorded estimated annual sales of USD 36 million in the U.S., according to IQVIA MAT November 2024 data.
