Actavis: FDA Approves Expanded Label For BOTOX - Quick Facts

(RTTNews) - Actavis plc (ACT) announced that the U.S. FDA has approved an expansion of the BOTOX (onabotulinumtoxinA) label for the treatment of adults with upper limb spasticity. The company said the expanded label approval for the two thumb flexor muscles is based on two additional randomized, multi-center, double-blind, placebo-controlled studies evaluating the efficacy and safety of BOTOX in patients with 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.