Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
Pediatric Labeling Date:  09/15/2017
 
Trade Name:  Adzenys ER
 
Generic Name or Proper Name (*):  amphetamine
 
Indications Studied:  Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older
 
Label Changes Summary:  *Safety and effectiveness have been established in pediatric patients with ADHD ages 6 to 17 years of age in three adequate and well-controlled clinical trials of up to 4 weeks in duration. *Safety and efficacy in pediatric patients younger than 6 years of age with ADHD have not been established. *Growth should be monitored during treatment with stimulants, including ADZENYS ER, and children who are not growing or gaining weight as expected may need to have their treatment interrupted. * Information on dosing, adverse reactions, PK parameters, and clinical trials.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Neos Therapeutics, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Stimulant
 
-
-