FDA Accepts sNDA for Allergan’s Botox
The US Food and Drug Administration (FDA) has accepted Allergan’s resubmission of its supplemental biologics license application (sBLA) for Botox (onabotulinumtoxinA) for treating adults with lower limb (involving ankle and toe muscles) spasticity in adults. A six-month review period has been assigned for the sBLA. The target action date is expected to be in the first quarter of 2016.
In April 2015, the FDA approved an expansion of the Botox 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 accumulative dose within three months from 360 to 400 units in adults treated for one or more indications.
On a prescription basis, Botox is a medicine that is injected into muscles and used to treat increased muscle stiffness in elbow, wrist, finger, and thumb muscles in people 18 years and older with upper limb spasticity.