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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:  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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Tris Pharma, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Stimulant
 
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