Lupin gets US FDA approval for Rufinamide Oral Suspension

Lupin announced it has received approval for its Rufinamide Oral Suspension, 40 mg/mL, from the United States Food and Drug Administration (US FDA), to market a generic equivalent of Banzel Oral Suspension, 40 mg/mL, of Eisai Inc.

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

Rufinamide Oral Suspension, 40 mg/ mL (RLD: Banzel) had estimated annual sales of $124.5 million in the US (IQVIA MAT September 2020).