Global pharma major Lupin Limited on Wednesday announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.
It is a generic equivalent of Briviact Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, of UCB Inc. The pharma major also announced that 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 USD 420 million in the U.S. as per IQVIA MAT September 2022.
Brivaracetam is used alone and in combination with other medications to control partial onset seizures (seizures that involve only one part of the brain) in adults, children, and infants 1 month of age and older. The drug works by decreasing abnormal electrical activity in the brain.
