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Lupin Limited secures FDA approval for Loteprednol Etabonate Ophthalmic Gel, enhancing treatment options for postoperative ocular inflammation and pain.
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Lupin Limited recently announced the US Food and Drug Administration (FDA) approval for the company’s Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Gel, 0.38%.1
Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid for the treatment of postoperative inflammation and pain following ocular surgery. It is the bioequivalent to Bausch & Lomb’s Lotemax SM Ophthalmic Gel. Additionally, Loteprednol Etabonate Ophthalmic Gel, 0.38% had an estimated annual sale of $29 million in the US, according to a press release.
Lupin is eligible for 180 days of drug exclusivity, as the company is the exclusive first-to-file for the product.
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