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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:  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 weight* Information on clinical trial, adverse reactions
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Shire
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Stimulant
 
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