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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:
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
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