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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:  02/27/2019
 
Trade Name:  Adhansia XR
 
Generic Name or Proper Name (*):  methylphenidate hydrochloride
 
Indications Studied:  Attention Deficit Hyperactivity Disorder
 
Label Changes Summary:  *Safety and effectiveness have been established in one adequate and well-controlled 6-week study in pediatric patients ages 6 to 12 years, and in one adequate and well-controlled 4-week study in pediatric patients ages 12 to 17 years. *Safety and effectiveness in pediatric patients under the age of 6 years have not been established. *The long-term efficacy of methylphenidate in pediatric patients has not been established. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *New dosage form.
 
PREA(P):  P
 
Sponsor:  Purdue Pharma L.P.
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Stimulant
 
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