Lupin receives approval from U.S. FDA for Loteprednol Etabonate Ophthalmic Suspension, 0.2%

Global pharma major Lupin Limited (Lupin) today announced that it 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 USD 29.1 million in the U.S. (IQVIA MAT October 2023).

Shares of Lupin Limited was last trading in BSE at Rs. 1282.75 as compared to the previous close of Rs. 1264.10. The total number of shares traded during the day was 46665 in over 2378 trades.

The stock hit an intraday high of Rs. 1293.20 and intraday low of 1265.05. The net turnover during the day was Rs. 59554986.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Approval USFDA LoteprednolEtabonate OphthalmicSuspension