Lupin receives USFDA approval for Brivaracetam Oral Solution 10 mg/mL

Lupin has received approval from the U.S. 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 1 month of age and older.

Following the approval, the company initiated the launch of Brivaracetam Oral Solution in the United States.

Brivaracetam Oral Solution (RLD Briviact) had an estimated annual sale of USD 135 million in the U.S. (IQVIA MAT December 2025).

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