The pharma major on Thursday announced that it has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA), Rufinamide tablets USP.
The approved ANDA is a generic equivalent of Banzel tablets of Eisai Inc. Rufinamide is used with other medications to control seizures in people who have Lennox-Gastaut syndrome (a severe form of epilepsy that begins during childhood and causes several types of seizures, behavioral disturbances, and developmental delays). Rufinamide belongs to a class of drugs called Anticonvulsants.
Lupin said the product will be manufactured at its facility in Goa, India.
Rufinamide tablets, (RLD Banzel) had estimated annual sales of $164 million in the U.S. (IQVIA MAT June 2022).
Lupin is an innovation-led transnational pharmaceutical company. 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.
The drug maker reported a net loss of Rs 89.1 crore in Q1 FY23 as against a net profit of Rs 542.5 crore in Q1 FY22. Total revenue from operations declined 12.3% YoY to Rs 3,743.8 crore during the quarter.
Shares of Lupin were up 0.16% to Rs 688.65 on the BSE.
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