Lupin gets tentative FDA approval for Brivaracetam Tablets
Lupin Limited said that it has been granted tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Brivaracetam Tablets, 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.
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.
Lupin Limited said that it will manufacture Brivaracetam Tablets at its facility in Nagpur, India.
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.