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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:  06/19/2017
 
Trade Name:  Cotempla XR-ODT
 
Generic Name or Proper Name (*):  methylphenidate
 
Indications Studied:  Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
 
Label Changes Summary:  *Safety and effectiveness have been established in pediatric patients 6 to 17 years in one adequate and well-controlled study in pediatric patients 6 to 12 years, pharmacokinetic data in adolescents, and safety information from other methylphenidate-containing products. *Safety and effectiveness in pediatric patients below 6 years of age have not been established. *The long-term efficacy of methylphenidate in pediatric patients has not been established. *Growth should be monitored during treatment with stimulants. *Information on dosing, adverse reactions, and clinical trial. *New dosage form.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Neos Therapeutics, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Stimulant
 
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