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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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