Lupin Limited on Thursday announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Rufinamide Tablets USP, 100 mg, 200 mg, and 400 mg, to market a generic equivalent of Banzel Tablets, 100 mg, 200 mg, and 400 mg, of Eisai Inc.
According to the company’s press statement, the product will be manufactured at Lupin’s facility in Goa, India. Rufinamide Tablets (RLD Banzel) had estimated annual sales of USD 164 million in the United States as per the IQVIA MAT June 2022.
Rufinamide is a prescription medicine used to treat the symptoms of Lennox-Gastaut Syndrome (seizures). According to experts, Rufinamide may be used alone or with other medications. Moreover, Rufinamide belongs to a class of drugs called Anticonvulsants.
The tablets are available for oral administration as film-coated tablets, scored on both sides.
Lennox-Gastaut syndrome is a severe form of epilepsy that begins during childhood and causes several types of seizures, behavioral disturbances, and developmental delays. According to experts, Rufinamide works by decreasing abnormal excitement in the brain.