ARTICLE | Clinical News

Cell-based Potency Assay regulatory update

March 5, 2012 8:00 AM UTC

Allergan said 2 regulatory agencies issued positive opinions for approval of its Cell-based Potency Assay (CBPA) to test the stability and potency of the company's Botox/Vistabel onabotulinumtoxinA. Ireland acted as reference member state under the mutual recognition procedure covering 14 EU member states for Botox, while France acted as reference member state covering 29 EU member states for Vistabel. Allergan said the in vitro, cell-based assay will reduce the use of animal-based assay testing for the products by about 95% over the next 3 years. ...