Arbor Pharmaceuticals Announces FDA Filing Acceptance Of New Drug Application For Investigational ADHD Prescription Stimulant Treatment
Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for AR19, an investigational immediate-release, amphetamine capsule for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children three through 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 November 15, 2020.
The AR19 NDA is supported by a comprehensive clinical program including studies that support . . .
