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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:  08/16/2016
 
Trade Name:  Kapvay
 
Generic Name or Proper Name (*):  clonidine
 
Indications Studied:  Postmarketing study
 
Label Changes Summary:  *In studies in juvenile rats, clonidine hydrochloride alone or in combination with methylphenidate had an effect on bone growth at clinically relevant doses and produced a slight delay in sexual maturation in males at 3 times the maximum recommended human dose (MRHD) for clonidine and methylphenidate. *Juvenile rat studies also showed a decrease in bone mineral density, mineral content, and decreased femur length. Decreased body weight was also observed. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Concordia Pharmaceuticals, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Non-stimulant ADHD treatment
 
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