Allergan: FDA Accepts BOTOX Resubmission For Lower Limb Spasticity In Adults

(RTTNews) - Pharmaceutical company Allergan Plc. (AGN) Thursday said the U.S. Food and Drug Administration has accepted the company's resubmission of its Supplemental Biologics License Application or sBLA for BOTOX (onabotulinumtoxinA) for the treatment of adults with lower limb (involving ankle and toe muscles) spasticity.

A six-month review period has been assigned for the sBLA. The Prescription Drug User Fee Act date is expected to be in the first quarter of 2016.

The resubmission provides additional data from a double-blind, placebo controlled study involving 468 patients with lower limb spasticity.

BOTOX is a prescription medicine injected into muscles to treat increased muscle stiffness in elbow, wrist, finger, and thumb muscles in people 18 years and older with upper limb spasticity.