Botox onabotulinumtoxinA regulatory update

FDA approved an sBLA for Botox onabotulinumtoxinA from Actavis to treat upper limb spasticity that expands the label for the indication to include 2 additional thumb muscles -- flexor pollicis longus and adductor pollicis. The approval also increases the maximum dose to 400 units from 360 in upper limb spasticity. Actavis gained the vacuum-dried purified botulinum toxin type A through its March acquisition of Allergan Inc. (see BioCentury, March 23). ...