Pharma major Lupin Ltd on Wednesday (December 27) said it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for loteprednol etabonate ophthalmic suspension, 0.2%.
"...regarding receipt of U.S. FDA approval for the company’s Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Suspension, 0.2%, to market a generic equivalent to the reference listed drug Alrex® Ophthalmic Suspension, 0.2%, of Bausch & Lomb Inc," according to a stock exchange filing.
This newly-approved medication serves as a generic equivalent to the reference listed drug (RLD) Alrex® Ophthalmic Suspension, 0.2%, by Bausch & Lomb Inc.
Loteprednol etabonate ophthalmic suspension, 0.2%, is specifically indicated for the temporary relief from the signs and symptoms associated with seasonal allergic conjunctivitis, offering a crucial solution for individuals grappling with allergic reactions affecting their eyes.
Manufactured at Lupin's state-of-the-art facility in Pithampur, India, this milestone approval opens the door for increased accessibility to an effective treatment for seasonal allergic conjunctivitis.
The product has estimated annual sales of $29.1 million in the US, according to IQVIA MAT October 2023, the company added.
Lupin develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs (active pharmaceutical ingredients) in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The company has 15 manufacturing sites, seven research centres, and more than 20,000 professionals working globally.
Also Read: Piramal Consumer Products to acquire Mumbai's Piramal Tower in Lower Parel for ₹875 crore
Shares of Lupin Ltd ended at ₹1,289, up by ₹6.25, or 0.49%, on the BSE.
