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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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