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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 l*New 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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