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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:  01/27/2016
 
Trade Name:  Adzenys XR-ODT
 
Generic Name or Proper Name (*):  amphetamine
 
Indications Studied:  Attention Deficit Hyperactivity Disorder in pediatric patients 6 to 17
 
Label Changes Summary:  * Safety and effectiveness have been established in pediatric patients 6 to 17 years in three clinical trials of up to 4 weeks in duration * Safety and efficacy in pediatric patients younger than 6 years of age have not been established. *Growth should be monitored during treatment with stimulants, including Adzenys XR-ODT, in pediatric patients 6 to 17 years who are not growing or gaining weight as expected because they may need to have their treatment interrupted. *Pediatric patients ages 6 to 12 years: Most common adverse reactions were loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever. Pediatric patients ages 13 to 17 years: Most common adverse reactions were loss of appetite, insomnia, abdominal pain, weight loss, and nervousness. *Information on dosing, adverse reactions, and clinical trials *New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Neos Therapeutics, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Stimulent
 
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