Pharma Exporters

USFDA nod to Lupin for generic Loteprednol Etabonate ophthalmic suspension

Pharma major Lupin Ltd on Wednesday said it has received approval from the US health regulator to market its generic Loteprednol Etabonate ophthalmic suspension indicated for temporary relief of seasonal allergic conjunctivitis. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Loteprednol Etabonate ophthalmic suspension, 0.2 per cent, Lupin said in a regulatory filing. It is a generic equivalent to the reference listed drug (RLD) Alrex ophthalmic suspension, 0.2 per cent of Bausch & Lomb Inc. The product will be manufactured at Lupin's Pithampur facility in India, the company added. Loteprednol Etabonate ophthalmic suspension, 0.2 per cent, is indicated for the temporary relief of signs and symptoms of seasonal allergic conjunctivitis. It had estimated annual sales of USD 29.1 million in the US market, Lupin said citing IQVIA MAT October 2023 data.

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