Pharmaceuticals firm Lupin Ltd on Thursday said it has received approval from the US health regulator to market its generic rufinamide tablets used in the treatment seizures.
The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of rufinamide tablets of strengths 100 mg, 200 mg, and 400 mg, Lupin said in a statement.
These are the generic equivalent of banzel tablets of same strengths of Eisai Inc, it added.
The product will be manufactured at Lupin's facility in Goa, the company said. Rufinamide tablets had estimated annual sales of USD 164 million in the US, Lupin said citing IQVIA MAT June 2022 data.