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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:  09/13/2019
Trade Name:  Mydayis
Generic Name or Proper Name (*):  mixed salts of a single-entity amphetamine
Indications Studied:  Attention Deficit Hyperactivity Disorder (ADHD)
Label Changes Summary:  *Safety and effectiveness have not been established in pediatric patients ages 12 years and younger. *Mydayis has been studied for the treatment of ADHD in pediatric patients 6 to 12 years in two placebo-controlled safety and efficacy trials. *In the first trial, pediatric patients 6 to 12 years experienced higher rates of adverse reactions in some cases compared to patients 13 years and older, including higher rates of insomnia (30% versus 8%) and appetite decreased (43% versus 22%). *Amphetamine systemic exposures in pediatric patients 6 to 12 years following a single dose were higher than those observed in adults at the same dose (72-79% higher Cmax and approximately 83% higher AUC). A second trial evaluated a lower dose than those approved for pediatric patients 13 to 17 years; efficacy was not demonstrated for the lower dose. *A safe and effective dose cannot be established in pediatric patients 12 years and younger. *Information on adverse reactions, PK parameters, and clinical trials. *Postmarketing requirement.
BPCA(B) and PREA(P):  B,P
Sponsor:  Shire
Pediatric Exclusivity Granted Date:  08/18/2019
Therapeutic Category:  CNS Stimulant