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:  11/19/2014
 
Trade Name:  Intuniv
 
Generic Name or Proper Name (*):  guanfacine
 
Indications Studied:  Attention Deficit Hyperactivity Disorder (ADHD)
 
Label Changes Summary:  *Two new pediatric studies were conducted. *A 15-week study conducted in 314 adolescents aged 13-17 years *A 12-week (for children aged 6-12) or 15-week (for adolescents aged 13-17)study conducted in 337 pediatric patients aged 6-17 years inclusive. *New dosing regimen (weight-based dosing up to 7 mg/day in adolescents) *Effectiveness for longer than 15 weeks has not been evaluated in controlled trials in pediatrics * Safety and efficacy in pediatric patients less than 6 years have not been established
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Shire
 
Pediatric Exclusivity Granted Date:  10/17/2014
 
Therapeutic Category:  Non-stimulant ADHD treatment
 
-
-