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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:  04/30/2009
 
Trade Name:  Axert
 
Generic Name or Proper Name (*):  almotriptan
 
Indications Studied:  Acute treatment of pediatric migraine in adolescent patients age 12-17 years
 
Label Changes Summary:  Safety and effectiveness established in patients 12  17 years. Efficacy on migraine associated symptoms (nausea, photophobia and phonophobia) was not established. Safety and effectiveness in pediatric patients < 12 years have not been established The most common adverse events were dizziness, somnolence, headache, paresthesia, nausea and vomiting. Safety and tolerability similar to adults. Information on dosing, adverse events, PK parameters, clinical study Patient population altered
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Ortho-McNeil
 
Pediatric Exclusivity Granted Date:  01/13/2009
 
NNPS:  FALSE'
 
Therapeutic Category:  Antimigraine
 
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