FDA approves Botox (onabotulinumtoxinA) extended indication for upper limb spasticity- Allergan/Actavis

Actavis plc which recently completed the acquisition of Allergan, announced that the FDA has approved an expansion of the Botox (onabotulinumtoxinA) label for the treatment of adults with upper limb spasticity. The expanded label now includes the addition of two thumb muscles: flexor pollicis longus, a muscle in the forearm that flexes the thumb; and adductor pollicis, a muscle in the hand that functions to adduct the thumb; increasing the maximum dose from 360 to 400 units for the treatment of upper limb spasticity.

The FDA also approved an increase to the maximum Botox cumulative dose within three months from 360 to 400 units in adults treated for one or more indications.