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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:
11/10/2010
Trade Name:
Vyvanse Capsules
Generic Name or Proper Name (*):
lisdexamfetamine
Indications Studied:
ADHD
Label Changes Summary:
Expanded indication to include adolescent patients ages13-17 years; previously approved for use in 6-12 years Most common adverse reactions were decreased appetite, insomnia, and decreased weightInformation on clinical trial, adverse reactions
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Shire
NNPS:
FALSE'
Therapeutic Category:
CNS Stimulant
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