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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:
10/19/2015
Trade Name:
Dyanavel XR
Generic Name or Proper Name (*):
amphetamine
Indications Studied:
Treatment of Attention Deficit Hyperactivity Disorder in 6 years and older
Label Changes Summary:
*Safety and effectiveness have been established in pediatric patients with ADHD ages 6-17 years. *Safety and efficacy in pediatric patients younger than 6 years with ADHD have not been established. *Growth should be monitored during treatment with stimulants, including Dyanavel XR, and children who are not growing or gaining weight as expected may need to have their treatment interrupted. *The adverse reaction profile of Dyanavel XR appears similar to other amphetamine extended-release products. *Information on adverse reactions, dosing, PK, and clinical trial. *New dosage form
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Tris Pharma, Inc.
NNPS:
FALSE
Therapeutic Category:
CNS Stimulant
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