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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:  09/27/2012
 
Trade Name:  QUILLIVANT XR
 
Generic Name or Proper Name (*):  methylphenidate hydrochloride
 
Indications Studied:  Treatment of Attention Deficit Hyperactivity Disorder
 
Label Changes Summary:  Safety and effectiveness have been established in pediatric patients ages 6 - 17 years Use in pediatric patients 6 - 12 years of age is supported by adequate and well-controlled studies. Use in 12 - 17 year olds is supported by the adequate and well-controlled studies of Quillivant XR in younger pediatric patients and additional pharmacokinetic data in adolescents, with safety information from other methylphenidate products The long-term efficacy of methylphenidate in pediatric patients has not been established Safety and efficacy in pediatric patients below the age of 6 years have not been established Growth should be monitored during treatment with stimulants, including Quillivant XR. Children who are not growing or gaining weight as expected may need to have their treatment interrupted Information on adverse reactions, pharmacokinetics and clinical tria lNew dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  NextWave Pharmaceuticals, Inc.
 
NNPS:  FALSE'
 
Therapeutic Category:  CNS Stimulant
 
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