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:  11/10/2010
 
Trade Name:  Vyvanse Capsules
 
Generic Name or Proper Name (*):  lisdexamfetamine
 
Indications Studied:  ADHD
 
Label Changes Summary:  * Expanded indication to include adolescent patients ages13-17 years; previously approved for use in 6-12 years * Most common adverse reactions were decreased appetite, insomnia, and decreased weight* Information on clinical trial, adverse reactions
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Shire
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Stimulant
 
-
-