Aucta wins FDA OK for generic Trileptal
Aucta’s oxcarbazepine oral suspension is used to treat seizure disorders.
The Food and Drug Administration has granted Aucta permission for oxcarbazepine oral suspension, 300 mg/5 ml, which is the generic of Novartis Trilepta.
The product is used to treat seizure disorders (epilepsy).
Aucta said it will commercialize this product in early 2023.
Oxcarbazepine oral suspension had a market value exceeding $74 million in the 12-month period ending October 2022, according to IQVIA.
[Read more: Aucta receives FDA OK for generic Perforomist]
"This is our fourth FDA approval and 2nd in the last 10 days," said Shoufeng Li, CEO of Aucta. "This is the start of the growth phase for our company, and we have many products working through the pipeline over the next three years."