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:  03/18/2015
 
Trade Name:  Intuniv
 
Generic Name or Proper Name (*):  guanfacine
 
Indications Studied:  Long-term maintenance treatment of ADHD
 
Label Changes Summary:  *Information added to labeling regarding a long-term, placebo-controlled monotherapy maintenance trial in 6-17 years *Increases in mean systolic and diastolic blood pressure, of approximately 3 mmHg and 1 mmHg respectively, above original baseline were observed upon discontinuation of Intuniv *Information on adverse reactions and clinical trial *Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Shire
 
Therapeutic Category:  Non-stimulant ADHD treatment
 
-
-