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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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