Posted by Michael Wonder on 04 Jul 2018
FDA approves Xeomin (incobotulinumtoxina) for adult patients with sialorrhoea
3 July 2018 - First and only neurotoxin approved for this indication in the United States.
Merz North America announced today that the U.S. FDA has approved the supplemental biologics license application for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhoea, or excessive drooling, in adult patients.
Xeomin was approved by the FDA for adult patients with sialorrhoea and is based on a Phase III, randomised, double-blind, placebo-controlled, multi-centre 184 patient trial.
