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U.S. Department of Health and Human Services

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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Shire
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Stimulant
 
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