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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:  02/25/2011
 
Trade Name:  Intuniv
 
Generic Name or Proper Name (*):  guanfacine
 
Indications Studied:  Adjunctive treatment with long-acting oral psychostimulants for the treatment of ADHD
 
Label Changes Summary:  Approved for use as adjunctive therapy with stimulants for the treatment of ADHD in pediatric patients 6 years and olderInformation on adverse reactions and clinical trialNew indicatio
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Shire
 
NNPS:  FALSE'
 
Therapeutic Category:  Non-stimulant ADHD treatment
 
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