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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:  09/12/2018
 
Trade Name:  Botox
 
Generic Name or Proper Name (*):  onabotulinumtoxinA
 
Indications Studied:  Prevention of headaches in adolescents with chronic migraine
 
Label Changes Summary:  *Safety and effectiveness in patients below the age of 18 years have not been established. *In a 12-week, multicenter, double-blind, placebo-controlled clinical trial, 123 adolescent patients (ages 12 to below 18 years) with chronic migraine were randomized to receive Botox 74 Units, Botox 155 Units, or placebo, for one injection cycle. This trial did not establish the efficacy of Botox, compared with placebo, for the prophylaxis of headaches in adolescents with chronic migraine. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Allergan, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antimigraine
 
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