FDA to Review Manipulation-Resistant Stimulant Med for ADHD
The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for AR19 (Arbor Pharmaceuticals) for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged ≥3 years. AR19 is an investigational immediate-release, amphetamine formulated to prevent the manipulation of the pellets in the capsules for nonmedical use. The formulation is intended to deter misuse and abuse via non-oral administration methods (ie, intranasal, intravenous and smoking).
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