Lupin rolls out Seizure drug Rufinamide in US
Mumbai: Pharma major Lupin Limited today announced the launch of Rufinamide Tablets USP, 200 mg and 400 mg in the United States market.
The product is a generic equivalent of Banzel Tablets, 200 mg and 400 mg, of Eisai Inc.
BANZEL (rufinamide) is an anti-epileptic drug indicated for:
• Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults.
Lennox–Gastaut syndrome is a rare, complex, and severe childhood-onset epilepsy. It is characterized by multiple and concurrent seizure types, cognitive dysfunction, and slow spike waves on electroencephalogram (EEG).
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 a 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.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas. The company invested 8.7% of its revenue in research and development in FY22. Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector.
