Lupin Receives Approval From U.S. FDA For Loteprednol Etabonate Ophthalmic Suspension

Global pharma major Lupin Limited (Lupin) on Wednesday 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 per cent, to market a generic equivalent to the reference listed drug (RLD) Alrex® Ophthalmic Suspension, 0.2 per cent, of Bausch & Lomb Inc., the company announced through an exchange filing.

The product will be manufactured at Lupin’s Pithampur facility in India.

Loteprednol Etabonate Ophthalmic Suspension, 0.2 per cent, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.

Lupin Limited shares

The shares of Lupin Limited on Wednesday at 3;p30 pm IST were at Rs 1,288, up by 0.42 per cent.

About Lupin

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.