Lupin receives approval for Rufinamide oral suspension

Pharma major, Lupin Limited on Monday said it has received approval from the US health regulator to market a generic drug used in the treatment of seizures associated with Lennox-Gastaut syndrome. It has received approval from the US Food and Drug Administration (USFDA)for its Rufinamide Oral Suspension in 40Â mg/ml strength.

In a regulatory filing, the company said, Lupin Limited, a global pharmaceutical company, has received approval for its Rufinamide Oral Suspension, 40 mg/ml, from the United States Food and Drug Administration (USFDA), to market a generic equivalent of Banzel® Oral Suspension, 40 mg/ml, of Eisai Inc."

The drug maker's product is the generic equivalent of Eisai Inc's Banzel oral suspension.

Rufinamide Oral Suspension, 40 mg/ml is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in pediatric patients 1 year of age and older, and in adults.

As per IQVIA MAT September 2020 data, Rufinamide Oral Suspension, 40 mg/ ml (RLD: Banzel®) had estimated annual sales of USD 124.5 million in the US.

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.

The Company enjoys a leadership position 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.

Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions and fifth in India by global revenues. The company invests 9.6 per cent of its revenues on research and development.