Lupin gets US FDA approval for Brivaracetam Tablets

Lupin has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, 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 facility in Nagpur, India.

Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, (RLD Briviact) had estimated annual sales of $420 million in the U.S. (IQVIA MAT September 2022).