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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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