Lupin receives USFDA tentative approval for Brivaracetam Tablets

Lupin today announced that it 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.

This product will be manufactured at Lupin's Nagpur facility in India. Brivaracetam Tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older.

Brivaracetam Tablets (RLD: Briviact Tablets) had estimated annual sales of USD 311 million in the U.S. (IQVIA MAT June 2021).

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