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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:  08/17/2007
 
Trade Name:  Provigil
 
Generic Name or Proper Name (*):  modafinil
 
Indications Studied:  Narcolepsy
 
Label Changes Summary:  Modafinil is not approved for use in pediatric patients for any indication Safety and effectiveness were not demonstrated in a controlled 6-week study in 165 pediatric patients 5-17 years with narcolepsy Serious rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with the use of modafinil In the controlled and open-label clinical studies, treatment emergent adverse events of the psychiatric and nervous system included Tourettes syndrome, insomnia, hostility, increased cataplexy, increased hypnagogic hallucinations and suicidal ideation Information on safety, AEs and clinical study
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Cephalon, Inc
 
Pediatric Exclusivity Granted Date:  03/21/2006
 
NNPS:  FALSE'
 
Therapeutic Category:  CNS Stimulant
 
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