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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:  10/21/2004
 
Trade Name:  Concerta
 
Generic Name or Proper Name (*):  methylphenidate
 
Indications Studied:  ADHD
 
Label Changes Summary:  * Expanded labeling for 13-17 year olds including information on dose, PK parameters, and AE profile * Increase in age resulted in increased apparent oral clearance * For patients new to methylphenidate: higher maximum recommended dosage for adolescents compared to children 6-12 years of age * Data are inadequate to determine whether chronic use of stimulants in children may cause suppression of growth. Therefore, growth should be monitored during treatment * Safety and efficacy in children <6 years have not been established
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Alza
 
Pediatric Exclusivity Granted Date:  12/04/2003
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Stimulant
 
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