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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
Sponsor:  Novartis
Therapeutic Category:  CNS Stimulant