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BOTOX Treatment in Pediatric Lower Limb Spasticity: Double-blind Study

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Trial Profile

BOTOX Treatment in Pediatric Lower Limb Spasticity: Double-blind Study

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Jul 2020

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Muscle spasticity
  • Focus Registrational; Therapeutic Use
  • Sponsors Allergan

    • Most Recent Events

    • 09 Jul 2020 According to an Allergan media release, the U.S. Food and Drug Administration (FDA) approved a supplemental Biologics License Application (sBLA) that supports expanded use of BOTOX for the treatment of spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy.
    • 07 Mar 2019 According to an Allergan media release, The pediatric upper limb spasticity indication has been designated a 6-month Priority Review with a Prescription Drug User Fee Act (PDUFA) date expected in the second quarter of this year. The pediatric lower limb spasticity indication will undergo a standard 10-month review with a PDUFA date expected in the fourth quarter of 2019.
    • 07 Mar 2019 According to an Allergan media release, the company announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental biologics license applications (sBLAs) to expand the onabotulinumtoxinA label for the treatment of pediatric patients (2 years of age and older) with upper and lower limb spasticity. sBLA submissions are based on data from four Phase 3 studies.
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