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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:  11/20/2014
 
Trade Name:  Kapvay Extended Release Tablets
 
Generic Name or Proper Name (*):  clonidine
 
Indications Studied:  Attention Deficit Hyperactivity Disorder (ADHD)
 
Label Changes Summary:  *One additional study was conducted. *A 40-week, dose optimization, randomized withdrawal study of 135 pediatric patients 6 to 17 years. *Blood pressure (BP): Mean increases in both systolic and diastolic BP (SBP/DBP) Hg were seen in drug treated patients. *Heart rate (HR): Mean decreases in HR were noted in drug treated patients
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Concordia Pharmaceuticals, Inc.
 
Therapeutic Category:  Non-stimulant ADHD treatment
 
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