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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:
04/26/2013
Trade Name:
Vyvanse Capsules
Generic Name or Proper Name (*):
lisdexamfetamine
Indications Studied:
Maintenance treatment of ADHD
Label Changes Summary:
Approved for the maintenance treatment of ADHD in pediatric patients 6-17 years Information on one short term efficacy trial and one maintenance trial in pediatric patients 6-17 years New indication
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Shire
NNPS:
FALSE'
Therapeutic Category:
CNS Stimulant
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