Lupin Receives FDA Approval For Generic Equivalent Of Alrex Ophthalmic Suspension
Lupin has secured approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application, marking a significant milestone for Loteprednol Etabonate Ophthalmic Suspension, 0.2 per cent, the company informed in a press statement on Wednesday.
This approval positions Lupin to market a generic equivalent to the reference listed drug (RLD) Alrex Ophthalmic Suspension, 0.2 per cent, produced by Bausch & Lomb. The manufacturing will take place at Lupin’s state-of-the-art facility in Pithampur, India the statement from the company read.
Loteprednol Etabonate Ophthalmic Suspension, 0.2 per cent, addresses the temporary relief of signs and symptoms associated with seasonal allergic conjunctivitis.
The generic equivalent, Loteprednol Etabonate Ophthalmic Suspension, 0.2 per cent (RLD Alrex), is anticipated to make a significant impact, with the reference product boasting estimated annual sales of USD 29.1 million in the U.S. market (IQVIA MAT October 2023).
