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EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for Aurobindo Receives FDA Approval for rufinamide tablets USP, 200mg and 400mg. Aurobindo Pharma’s rufinamide tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Banzel Tablets, manufactured by Eisai Inc.
Rufinamide tablets, are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.
Rufinamide tablets, has an estimated market size of US $115 Million for the twelve months ending April 2023, as per IQVIA.
