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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
 
PREA(P):  P
 
Sponsor:  Novartis
 
NNPS:  FALSE'
 
Therapeutic Category:  CNS Stimulant
 
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