28Dec 2023
Lupin Limited Secures FDA Approval for Generic Equivalent of Alrex® Ophthalmic Suspension, 0.2%

Lupin Limited Secures FDA Approval for Generic Equivalent of Alrex® Ophthalmic Suspension, 0.2%

Global pharmaceutical company Lupin Limited 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%. This generic equivalent to Bausch & Lomb Inc.'s Alrex® Ophthalmic Suspension, 0.2%, is set to be manufactured at Lupin's Pithampur facility in India. Indicated for the temporary relief of signs and symptoms of seasonal allergic conjunctivitis, the product addresses a market with an estimated annual sales value of USD 29.1 million in the U.S. (IQVIA MAT October 2023).

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