Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (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.
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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
