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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:
02/23/2007
Trade Name:
Vyvanse Capsules
Generic Name or Proper Name (*):
lisdexamfetamine
Indications Studied:
Treatment of ADHD in children 6 to 12 years of age
Label Changes Summary:
Effectiveness established in two studies of patients 6-12 years of age Long-term effectiveness of more than 4 weeks has not been established Studies waived in children 0-5 years of age and deferred in children 13-17 years of age New active ingredient
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
New River
NNPS:
FALSE'
Therapeutic Category:
CNS Stimulant
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