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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:  05/14/2015
 
Trade Name:  Treximet
 
Generic Name or Proper Name (*):  sumatriptan/naproxen
 
Indications Studied:  Acute treatment of migraine with or without aura
 
Label Changes Summary:  * Safety and efficacy for the acute treatment of migraine in pediatric patients 12 to 17 years of age were established in a double-blind, placebo-controlled trial *Safety and effectiveness in pediatric patients under 12 years of age have not been established *The safety of treating an average of more than 2 migraine headaches in pediatric patients in a 30-day period has not been established *Information on dosing, adverse reactions, pharmacokinetics clinical studies *Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Pernix Therapeutics
 
Pediatric Exclusivity Granted Date:  04/16/2015
 
NNPS:  FALSE
 
Therapeutic Category:  Antimigraine
 
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