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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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