Indoco Remedies and Lupin Receive USFDA Approval for Brivaracetam Oral Solution

Indoco Remedies and Lupin have both received final approval from the US Food and Drug Administration for their Abbreviated New Drug Applications for Brivaracetam Oral Solution, 10 mg/mL, a generic version of UCB, Inc.'s Briviact. Indoco's approval supports its presence in regulated markets, with manufacturing in Goa, while Lupin has initiated the product launch in the US. Brivaracetam is prescribed for partial-onset seizures in patients aged one month and older, with estimated US annual sales of $135 million for the reference drug.