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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  09/02/2009
 
Trade Name:  Intuniv
 
Generic Name or Proper Name (*):  guanfacine
 
Indications Studied:  ADHD
 
Label Changes Summary:  * Efficacy established in 2 controlled clinical trials in children 6-17 years * Safety and efficacy in pediatric patients< 6 years have not been established * In clinical trials, there were dose and exposure-related risks for adverse events (AEs) including hypotension, bradycardia, and sedative events. Somnolence and sedation were reported in 38% on guanfacine vs. 12% on placebo in children and adolescents with ADHD, especially during initial use * Information on dosing, clinical trials, and AEs * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Shire
 
NNPS:  FALSE
 
Therapeutic Category:  Non-stimulant ADHD treatment
 
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