Posted by Michael Wonder on 28 Jan 2026
Otsuka announces FDA acceptance and priority review of new drug application for centanafadine for the treatment of ADHD in children, adolescents, and adults
27 January 2026 - The PDUFA target action date is 24 July 2026.
Otsuka today announce that the US FDA has accepted for priority review the new drug application for centanafadine, an investigational, once daily extended release capsule and the first in class norepinephrine, dopamine, and serotonin reuptake inhibitor, for the treatment of attention deficit hyperactivity disorder in children, adolescents, and adults.
