FDA extends indication for ADHD treatment formulation to adolescent years

Article

The US Food and Drug Administration (FDA) recently approved Adderall XR (an extended-release formulation of mixed salts of amphetamine) as a once-daily treatment for attention deficit hyperactivity disorder in adolescents 13 to 17 years old. That action bridges an "indication gap" between earlier approval of the product for patients 6 to 12 years old and for older (18 years) adolescents and adults.

The US Food and Drug Administration (FDA) recently approved Adderall XR (an extended-release formulation of mixed salts of amphetamine) as a once-daily treatment for attention deficit hyperactivity disorder in adolescents 13 to 17 years old. That action bridges an "indication gap" between earlier approval of the product for patients 6 to 12 years old and for older (18 years) adolescents and adults.

The FDA based its approval on data that the drug's manufacturer, Shire Pharmaceuticals, provided in a supplement to its new drug application, including results of a pharmacokinetic study and a placebo-controlled, fixed-dose, clinical trial of a range of doses of once-daily Adderall XR in adolescents with ADHD. In a randomized, double-blind, placebo-controlled clinical trial, the drug was more effective than placebo in treating the symptoms of ADHD symptoms in this group of patients.

Newsletter

Access practical, evidence-based guidance to support better care for our youngest patients. Join our email list for the latest clinical updates.

Recent Videos
Discussing phase 3 data of Panzyga for PANS, with Michael Daines, MD
Diet, mental health, and pediatric nutrition, with Colleen Sloan, PA-C, RDN
Discussing social media and potential nutrition impacts with Colleen Sloan, PA-C, RDN
Peter S. Jensen, MD
Rakesh Jain, MD, MPH
Rakesh Jain, MD, MPH
Tanya Altmann, MD
Alan Percy, MD
Related Content
© 2025 MJH Life Sciences

All rights reserved.