Lupin receives USFDA nod for generic drug

Pharma company Lupin 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 syndromeThe company has received approval from the US Food and Drug Administration USFDAfor its Rufinamide Oral Suspension in 40 mgmL strength, Lupin said in a statement. The drug makers product is the generic equivalent of Eisai Incs Banzel oral suspension.

Pharma company Lupin 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

The company has received approval from the US Food and Drug Administration (USFDA)for its Rufinamide Oral Suspension in 40 mg/mL strength, Lupin said in a statement. The drug maker's product is the generic equivalent of Eisai Inc's Banzel oral suspension. Rufinamide Oral Suspension is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in pediatric patients of one year of age and older, and in adults. As per IQVIA MAT September 2020 data, the product had annual sales of around USD 124.5 million in the US market.