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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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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
PREA(P):
P
Sponsor:
Shire
Therapeutic Category:
Non-stimulant ADHD treatment
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