Lupin gets tentative FDA approval for Brivaracetam Tablets

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Lupin Limited said that it has been granted tentative approval from the (FDA) for its abbreviated new drug application (ANDA) for , 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.

Brivaracetam Tablets is a generic equivalent of Briviact Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, of UCB Inc.

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The drug is indicated for the treatment of partial-onset seizures in patients, aged four and over.

As per IQVIA MAT June 2021, the estimated annual sales of Brivaracetam Tablets in the US are $311 million.

Limited said that it will manufacture Brivaracetam Tablets at its facility in Nagpur, .

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In June 2021, another Indian pharma company – Zydus Cadila had secured tentative approval from the FDA to market Brivaracetam Tablets in the strengths of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.

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