Lupin receives tentative US FDA approval for Brivaracetam tablets

Lupin has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg and 100 mg, to market a generic equivalent of Briviact tablets, 10 mg, 25 mg, 50 mg, 75 mg and 100 mg, of UCB Inc. The product will be manufactured at Lupin’s Nagpur facility in India, Lupin said in a statement.

It notified that Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older.

“Brivaracetam tablets had estimated annual sales of $311 million in the US (IQVIA MAT June 2021),” it added.