Lupin Ltd announced on Wednesday that the generic version of Brivaracetam tablets, which is used to treat partial-onset seizures, has been approved by the US Food and Drug Administration.
The approval by the US Food and Drug Administration (USFDA) is for Brivaracetam tablets of strengths 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, the company said in a regulatory filing.
These are the generic equivalent of Briviact tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, of UCB Inc, it added.
The product will be manufactured at Lupin's facility in Nagpur.
The Brivaracetam tablets had estimated annual sales of USD 420 million in the US, the company said citing IQVIA MAT September 2022 data.
With inputs from Agencies.
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