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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:  06/29/2010
 
Trade Name:  Daytrana
 
Generic Name or Proper Name (*):  methylphenidate
 
Indications Studied:  ADHD
 
Label Changes Summary:  Expanded pediatric indication to include adolescent patients ages13-17 years The most commonly reported adverse reactions in a trial in patients 13-17 years included appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia. The majority of patients had erythema at the application site Information on PK parameters, Adverse Event profile and clinical studies
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Shire
 
NNPS:  FALSE'
 
Therapeutic Category:  CNS Stimulant
 
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