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.

Recent Videos
Rakesh Jain, MD, MPH
Rakesh Jain, MD, MPH
Tanya Altmann, MD
Alan Percy, MD
Alan Percy, MD
Perry Roy, MD
Perry Roy, MD | Image Credit: Carolina Attention Specialists
Donna Hallas, PhD, CPNP, PPCNP-BC, PMHS, FAANP, FAAN
Breaking down toddler formulas and the confusion associated with naming, labeling | Image Credit: © University of Kentucky - © University of Kentucky - stock.adobe.com.
Related Content
© 2024 MJH Life Sciences

All rights reserved.