Allergan’s BOTOX (onabotulinumtoxinA) Receives FDA’s Approval for Upper Limb Spasticity in Pediatric Patients

Allergan’s BOTOX (onabotulinumtoxinA) Receives FDA’s Approval for Upper Limb Spasticity in Pediatric Patients

Shots:

  • The approval is based on two P-III studies result assessing BOTOX (3-6 units/kg) in 200 pediatric patients with upper limb spasticity aged 2-17yrs. for 12wks. followed by a one-year extension study
  • Additionally, sBLA for using BOTOX in treating pediatric patients with lower limb spasticity is under FDA’s review with its expected approval in Q4’19
  •  BOTOX is a neurotoxin therapy injected in the muscles to treat increased muscle stiffness & eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) and has received six-month Priority Review by the FDA

Click here to read full press release/ article | Ref: Allergan | Image: Spicy IP