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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:  06/20/2017
 
Trade Name:  Mydayis
 
Generic Name or Proper Name (*):  mixed salts of a single-entity amphetamine
 
Indications Studied:  Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
 
Label Changes Summary:  *Safety and effectiveness in pediatric patients with ADHD ages 13 to 17 years have been established in two placebo-controlled clinical studies. *Safety and effectiveness have not been established in pediatric patients ages 12 years and younger. *In clinical trials, pediatric patients 6 to 12 years of age 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 (both d- and l-) in patients 6 to 12 years following a single dose were higher than those observed in adults at the same dose. *Information on PK parameters, adverse reactions and clinical trials. *New dosage form.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Shire
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Stimulant
 
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