India-based global pharma company Lupin Limited (BSE:500257) (NSE:LUPIN) announced on Tuesday that it has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution 10 mg/mL.
Brivaracetam is the bioequivalent to UCB Inc's Briviact Oral Solution, 10 mg/mL and is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
Following the FDA approval, Lupin has commenced the launch of Brivaracetam Oral Solution in the United States.
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