Lupin receives FDA tentative nod for generic Briviact
Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients age 4 years old and older.
Lupin has received the Food and Drug Administration’s tentative approval for brivaracetam tablets, in dosage strengths of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg,
The medication is the generic of UCB’s Briviact tablets.
Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients age 4 years old and older.
Brivaracetam tablets have a market value of approximately $311 million, according to IQVIA June 2021 data.
This product will be manufactured at Lupin’s Nagpur facility in India.