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