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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:  10/18/2019
Trade Name:  Botox
Generic Name or Proper Name (*):  onabotulinumtoxinA
Indications Studied:  Treatment of lower limb spasticity in pediatric patients 2 to 17 years of age
Label Changes Summary:  *Safety and effectiveness have been established in pediatric patients 2 to 17 years. *Safety and effectiveness of have been established by evidence from adequate and well-controlled studies of Botox in patients 2 to 17 years with lower limb spasticity. However, treatment Botox for this indication is not intended to substitute for usual standard of care rehabilitation regimens. *A pediatric assessment for Botox demonstrated that it is safe and effective in another pediatric population. However, Botox is not approved for such patient population due to marketing exclusivity for another botulinum toxin. *Safety and effectiveness in pediatric patients below the age of 2 years have not been established. *Information on dosing, adverse reactions, and clinical trials. *Postmarketing study.
Sponsor:  Allergan
Therapeutic Category:  Neuromuscular blocking agent