Posted by Michael Wonder on 13 May 2020
Arbor Pharmaceuticals announces FDA filing acceptance of new drug application for AR19, an investigational ADHD prescription stimulant treatment specifically designed to resist physical manipulation for non-medical misuse or abuse
13 May 2020 - If approved, AR19 would be the first-ever FDA approved ADHD stimulant medication designed to resist manipulation for non-medical use, which may help to deter misuse and abuse by intranasal, intravenous and smoking routes of administration.
Arbor Pharmaceuticals announced today that the U.S. FDA has accepted for filing its new drug application for AR19, an investigational immediate-release, amphetamine capsule for the treatment of attention-deficit/hyperactivity disorder in children 3-17 years of age and in adults 18 and older. AR19 has been specifically designed to resist potential manipulation.
The FDA has set a Prescription Drug User Fee Act target action date of 15 November 2020.
