Lupin gets USFDA nod for Rufinamide Oral Suspension

Rufinamide Oral Suspension, 40 mg/mL

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Lupin gets USFDA nod for Rufinamide Oral Suspension
USFDA Approval

Last Updated on October 17, 2024 by The Health Master

Lupin announced it 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.

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).


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