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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:  12/04/2015
 
Trade Name:  QuilliChew ER
 
Generic Name or Proper Name (*):  methylphenidate hydrochloride
 
Indications Studied:  Attention Deficit Hyperactivity Disorder
 
Label Changes Summary:  *Indicated for use in pediatric patients pediatric patients ages 6 to 17 years. *Use in these age groups is based on one adequate and well-controlled clinical study in pediatric patients 6 to 12 years old, pharmacokinetic data in adolescents and adults, and safety information from other methylphenidate-containing products. *The safety and effectiveness of in pediatric patients under six years have not been evaluated. *Long-term effectiveness of QuilliChew ER has not been established. *Growth should be monitored during treatment with CNS stimulants, including QuilliChew ER. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted. *Information on dosing, adverse events, clinical trial. *New dosage form.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Pfizer
 
NNPS:  FALSE
 
Therapeutic Category:  CNS stimulant
 
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