FDA extends indication for ADHD treatment formulation to adolescent years
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.
Associations between prenatal metal mixture exposure and negative infant outcomes
