Lupin gets US FDA approval for Loteprednol Etabonate Ophthalmic Suspension, 0.2%

Lupin has received approval from the United States Food and Drug Administration (US 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. 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 USD 29.1 million in the US (IQVIA MAT October 2023).