The U.S. Food and Drug Administration has approved a non-animal, cell-based assay for use in the stability and potency testing of Allergans´ leading brands BOTOX® and BOTOX® Cosmetic (Invitrojobs reported). Allergan has stated that this will enable the company to reduce animal testing of BOTOX®, BOTOX® Cosmetic and VISTABEL® by up to 95% in three years. The meeting with Allergan confirmed the company aims to end animal testing for the commercial (batch) release of BOTOX®, Botox Cosmetic and VISTABEL® once all stages of regulatory approval has been cleared. They also discussed their plans to work with the European medicines regulators so that this assay can be used for the commercial batch release of BOTOX® and VISTABEL® vials sold in Europe.
It’s important to note that this assay is specific for the products made and sold by Allergan (BOTOX®, BOTOX® Cosmetic and VISTABEL®) and does not apply to other botulinum toxins.
Read more: http://www.eceae.org/