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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:  05/26/2005
 
Trade Name:  Focalin XR Extended-Release Capsules
 
Generic Name or Proper Name (*):  dexmethylphenidate
 
Indications Studied:  Treatment of Attention-Deficit Hyperactivity Disorder in children 6 years of age and older
 
Label Changes Summary:  * Should not be used in children under 6 years of age * Effectiveness in patients age 6 years of age and older was established in clinical studies * PK studies also conducted * Long-term effects in children have not been established * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Novartis
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Stimulant
 
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