Lupin bags USFDA okay for seizure treatment drug Rufinamide
Rufinamide Tablets will be manufactured at Lupin’s facility in Goa, India.
Mumbai: Global pharma major, Lupin Limited, today announced that the company has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Rufinamide Tablets USP, 100 mg, 200 mg, and 400 mg.
The product is a generic equivalent of Banzel Tablets, 100 mg, 200 mg, and 400 mg, of Eisai Inc.
Rufinamide is used with other medications to control seizures in patients who have Lennox-Gastaut syndrome. Rufinamide belongs to a class of drugs known as Anticonvulsants.
Rufinamide Tablets will be manufactured at Lupin's facility in Goa, India.
Read also: Lupin gets USFDA nod for partial-onset seizures drug Brivaracetam
Rufinamide Tablets (RLD Banzel) had estimated annual sales of USD 164 million in the U.S. (IQVIA MAT June 2022).
Medical Dialogues Team had earlier announced that the company had received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.
Read also: Lupin gets USFDA nod for partial-onset seizures drug Brivaracetam
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 Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women's health areas.
Read also: Lupin secures USFDA nod for Azilsartan Medoxomil Tablets
