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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:  10/23/2009
Trade Name:  Focalin XR
Generic Name or Proper Name (*):  dexmethylphenidate
Indications Studied:  ADHD
Label Changes Summary:  * Revised maximum daily dosing due to dose-response studies. Doses above 30 mg/day in pediatrics and 40 mg/day in adults have not been studied and are not recommended * Dosing should be individualized to patient needs and response. * There was no clear benefit of the higher doses compared to the lower doses. Adverse events and discontinuations were dose-related. * New dosing regimen; new dosage strength (30 mg capsule)
Product Labeling:  Labeling  Opens a new window
Sponsor:  Novartis
Therapeutic Category:  CNS Stimulant