Lupin gets tentative nod from USFDA to market partial-onset seizures drug

Drug firm Lupin on Monday said it has received tentative nod from the US health regulator to market its generic Brivaracetam tablets used for the treatment of partial-onset seizures.

The company has received tentative approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, Lupin said in a statement.

The product is a generic version of UCB Biopharma SPRL's Briviact tablets in the same strengths, it added. These tablets will be manufactured at the company's Nagpur facility, the statement said.

Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older, Lupin said.

As per IQVIA MAT June 2021 data, Brivaracetam tablets had estimated annual sales of USD 311 million in the US, it added.

Shares of Lupin closed at Rs 967.30 on BSE, down 0.95 percent from its previous close.