Lupin receives US FDA approval for Brivaracetam Oral Solution 10 mg/mL
Company initiates US launch following ANDA approval for bioequivalent to Briviact
Lupin has received approval from the U.S. Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution 10 mg/mL.
Brivaracetam is the bioequivalent to Briviact Oral Solution, 10 mg/mL, of UCB, Inc., and is indicated for the treatment of partial-onset seizures in patients one month of age and older. Following the approval, the company initiated the launch of Brivaracetam Oral Solution in the United States.
Brivaracetam Oral Solution (reference listed drug Briviact) had an estimated annual sale of USD 135 million in the United States for the twelve months ending December 2025, according to IQVIA MAT December 2025.