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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:
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
PREA(P):
P
Sponsor:
Shire
NNPS:
FALSE
Therapeutic Category:
CNS Stimulant
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