The FDA has approved the expanded use of Botox® (onabotulinumtoxinA; Allergan) for the treatment of spasticity in pediatric patients aged ≥2 years, including those with lower limb spasticity caused by cerebral palsy.
The FDA has granted Orphan Drug designation to RT001 (Retrotope) for the treatment of progressive supranuclear palsy (PSP).
The FDA has approved Botox for the treatment of lower limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy. The treatment was already approved for pediatric upper limb spasticity earlier this year.
The Food and Drug Administration (FDA) has expanded the indication of Dysport (abobotulinumtoxinA; Ipsen) to include the treatment of upper limb spasticity in patients aged 2 years and older, excluding spasticity caused by cerebral palsy. Previously, Dysport was only approved to treat lower limb spasticity in patients aged 2 years and older. The approval was…
The Food and Drug Administration (FDA) has approved Myobloc (rimabotulinumtoxinB injection; US WorldMeds) for the treatment of chronic sialorrhea in adults. The approval was based on multiple studies, including a double-blind, placebo-controlled trial, followed by an open-label treatment period, in 187 patients with chronic, troublesome sialorrhea for at least 3 months. Patients were randomized to…
The Food and Drug Administration (FDA) has approved Botox (onabotulinumtoxinA; Allergan) for the treatment of upper limb spasticity in pediatric patients 2-17 years of age. The approval was based on data from two phase 3 trials: a 12-week study that evaluated the efficacy and safety of Botox in 234 pediatric patients with upper limb spasticity…
The FDA has approved Xeomin (incobotulinumtoxinA; Merz) as a first-line treatment for blepharospasm in adults.
Allergan announced that the Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Applications (sBLAs) for Botox (onabotulinumtoxinA) injection for the treatment of patients aged ≥2 years with upper and lower limb spasticity.
Findings seen among people with dystonia or spasticity treated with botulinum toxin type A
Case report of 66-year-old woman whose implantable pulse generator switched off after lightning strike
