20 August 2015 - Allergan plc, a leading global pharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's resubmission of its Supplemental Biologics License Application (sBLA) for Botox (onabotulinumtoxin A) for the treatment of adults with lower limb (involving ankle and toe muscles) spasticity in adults. A six-month review period has been assigned for the sBLA. The Prescription Drug User Fee Act (PDUFA) date is expected to be in the first quarter of 2016.

"We have continued to work closely with the FDA to prepare our resubmission and we are confident that the additional information requested is addressed," said Mitchell F. Brin, M.D., Senior Vice President Global Development and Chief Scientific Officer, Botox. "This FDA acceptance represents our ongoing commitment to research and development, and efforts to bring to market the first-approved focal therapy for lower limb spasticity for physicians and patients."

For more details, go to: http://www.allergan.com/NEWS/News/Thomson-Reuters/U-S-FDA-Accepts-BOTOX-onabotulinumtoxinA-Resubmis