SHIRE FILES NDA FOR ADHD DRUG

Shire announced that it has submitted a new drug application (NDA) to the FDA for SPD465, an investigational amphetamine compound for the treatment of attention-deficit/hyperactivity disorder (ADHD) in the adult population. SPD465 has the same active ingredient as Adderall XR (mixed salts of a single-entity amphetamine product), but is designed to provide ADHD symptom control for up to 16 hours. Upon approval, the drug will be the first ADHD stimulant that controls inattention, hyperactivity and impulsivity for up to 16 hours.