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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:  01/28/2017
 
Trade Name:  Vyvanse Chewable Tablet
 
Generic Name or Proper Name (*):  lisdexamfetamine
 
Indications Studied:  Attention Deficit Hyperactivity Disorder in pediatric patients ages 6 to 17 years
 
Label Changes Summary:  *New Vyvanse chewable tablets approved. Vyvanse chewable tablets must be chewed thoroughly before swallowing. *Vyvanse capsules can be substituted with Vyvanse chewable tablets on a unit per unit/ mg per mg basis (e.g., 30 mg capsules for 30 mg chewable tablet). *Information on pharmacokinetics. *New formulation.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Shire
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Stimulant
 
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