Lupin gets USFDA nod for Rufinamide Oral Suspension

Rufinamide Oral Suspension, 40 mg/mL

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USFDA
Picture: Pixabay

Last Updated on December 23, 2020 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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