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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
Alza
Pediatric Exclusivity Granted Date:
12/04/2003
NNPS:
FALSE'
Therapeutic Category:
CNS Stimulant
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