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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:  09/25/2019
 
Trade Name:  Dysport
 
Generic Name or Proper Name (*):  abobotulinumtoxinA
 
Indications Studied:  Treatment of upper limb spasticity in pediatric patients 2 years and older
 
Label Changes Summary:  *Approved for the treatment of upper limb spasticity in pediatric patients 2 years and older, excluding spasticity caused by cerebral palsy. *Safety and effectiveness have been established by evidence from adequate and well-controlled studies in patients 2 years and older with upper limb spasticity. *A pediatric study demonstrated that Dysport is safe and effective in another pediatric population. However, Dysport 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 trial. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Ipsen Biopharmaceuticals, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antispasmodic
 
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