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New Pediatric Labeling Information Database - Detail
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Pediatrics
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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