Lupin receives USFDA approval for Rufinamide Oral Suspension

Lupin announced that it has received approval for its Rufinamide Oral Suspension, 40 mg/ml, from the United States Food and Drug Administration, 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 1 year of age and older, and in adults.

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

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