Lupin Receives FDA Approval for Generic Loteprednol Etabonate Ophthalmic Suspension
12/29/2023
Mumbai, India-based Lupin announced that it has received approval from the FDA for its abbreviated new drug application for Loteprednol etabonate ophthalmic suspension, 0.2%. The formuation is a generic equivalent to the reference listed drug Alrex Ophthalmic Suspension, 0.2% (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 $29.1 million in the US, according to data from IQVIA (October 2023).