Lupin receives USFDA’s approval for Loteprednol Etabonate Ophthalmic Suspension

27 Dec 2023 Evaluate

Lupin has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Suspension, 0.2%, to market a generic equivalent to the reference listed drug (RLD) Alrex Ophthalmic Suspension, 0.2%, of Bausch & Lomb Inc. 

The product will be manufactured at Lupin’s Pithampur facility in India. Loteprednol Etabonate Ophthalmic Suspension, 0.2%, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis. Loteprednol Etabonate Ophthalmic Suspension, 0.2% (RLD Alrex), had estimated annual sales of $29.1 million in the U.S. (IQVIA MAT October 2023).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.


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