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Global pharma major Lupin Limited (Lupin) announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for loteprednol etabonate ophthalmic gel, 0.38%, to market a generic equivalent of Lotemax SM ophthalmic gel of Bausch & Lomb Inc. Lupin is the exclusive first-to-file for this product and may be eligible to receive a 180-day exclusivity. This product would be manufactured at Lupin’s Pithampur facility in India.
Loteprednol etabonate ophthalmic gel, 0.38% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
Loteprednol etabonate ophthalmic gel, 0.38% (Lotemax SM) had an estimated annual sale of USD 36 million in the US (IQVIA MAT November 2024).
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