Allergan's BOTOX (onabotulinumtoxinA) Receives the US FDA's Approval for Pediatric Patients with Lower Limb Spasticity Excluding Spasticity Caused by Cerebral Palsy
Shots:
- The FDA’s approval is based on P-III study assessing the BOTOX in 300+ pediatric patients aged 2-17yrs. being treated for lower limb spasticity. The study included patients with cerebral palsy- but the approved indication excludes lower limb spasticity caused by cerebral palsy due to marketing exclusivity by another company
- The approval marks the 11th BOTOX therapeutic indication and comes 30yrs. after the first indications were approved and recently has been approved for pediatric upper limb spasticity in H1’2019
- 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)
Click here to read full press release/ article | Ref: PRNewswire | Image: Business Insider
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