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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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