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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:  06/20/2019
 
Trade Name:  Botox
 
Generic Name or Proper Name (*):  onabotulinumtoxinA
 
Indications Studied:  Treatment of upper limb spasticity in pediatric patients 2 to 17 years of age
 
Label Changes Summary:  *Safety and effectiveness for the treatment of upper limb spasticity have been established in pediatric patients 2 to 17 years of age, in a clinical study of 234 patients. *Safety and effectiveness in pediatric patients below the age of 2 years have not been established. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Allergan
 
NNPS:  FALSE
 
Therapeutic Category:  Antispasmodic
 
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