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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  10/23/2009
 
Trade Name:  Focalin XR
 
Generic or Proper Name (*):  dexmethylphenidate
 
Indications Studied:  ADHD
 
Therapeutic Category:  CNS Stimulant
 
Ages Studied:  6 years and older
 
Study #:  1
 
Study Type:  Efficacy/Safety/Tolerability
 
Study Design:  Single-Blind/Placebo/Parallel Group
 
No Patients:  253
 
No Centers:  34
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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