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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:  10/13/2004
 
Trade Name:  Imitrex Nasal Spray
 
Generic Name or Proper Name (*):  sumatriptan
 
Indications Studied:  Migraine
 
Label Changes Summary:  * Five clinical trials evaluating oral sumatriptan in pediatric patients ages 12 -17 years did not establish the safety and effectiveness when compared to placebo * Postmarketing experience documents that serious AEs rarely reported in adults, including stroke, visual loss, and death have occurred in the pediatric population after use of subcutaneous, oral, and/ or nasal sumatriptan. * Since clinical data to determine the frequency of serious adverse events in pediatric patients who might receive injectable, oral, and/ or intranasal sumatriptan are not presently available, the use of sumatriptan in patients aged younger than 18 years is not recommended
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Glaxo
 
Pediatric Exclusivity Granted Date:  02/18/2004
 
NNPS:  FALSE
 
Therapeutic Category:  Antimigraine
 
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