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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
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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