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Lupin receives USFDA nod for rufinamide tablets to treat seizures

Pharmaceuticals firm Lupin Ltd on Thursday said it has received approval from the US health regulator to market its generic rufinamide tablets to treat seizures, manufacturing to begin in Goa.

Topics
health | Lupin | USFDA

Press Trust of India  |  New Delhi 



A large drug firm has 12-15 therapy divisions, and if each launches a few drugs, the company brings to the market 30-50 brands a year.
USFDA approves manufacturing of generic drug to treat seizures.

Pharmaceuticals firm Ltd on Thursday said it has received approval from the US 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, 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, said citing IQVIA MAT June 2022 data.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)


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First Published: Thu, August 18 2022. 15:41 IST

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