ARTICLE | Clinical News

Botox Cell-based Potency Assay regulatory update

July 4, 2011 7:00 AM UTC

FDA approved Allergan's Botox Cell-based Potency Assay (CBPA) to test the stability and potency of the company's Botox onabotulinumtoxinA and Botox Cosmetic. The assay, which will be launched in the U.S. immediately, is the first approved by FDA for any botulinum neurotoxin. Allergan said the in vitro, cell-based assay will reduce the use of animal-based assay testing for the Botox products by about 95% over the next 3 years. ...