Allergan Receives FDA Approval for First-of-Its-Kind, Fully in vitro, Cell-Based Assay for BOTOX® and BOTOX® Cosmetic (onabotulinumtoxinA)
–Represents R&D Breakthrough in Commitment to Animal-Free Stability and Potency Testing for BOTOX® and BOTOX® Cosmetic–
IRVINE, Calif.–(BUSINESS WIRE)– Allergan, Inc. (NYSE:AGN) today announced the United States Food and Drug Administration (FDA) has approved a fully in vitro, cell-based assay for use in the stability and potency testing of BOTOX® (onabotulinumtoxinA) and BOTOX® Cosmetic. The newly approved assay will be implemented immediately for release of product for sale in the United States. Allergan estimates that use of the new assay will reduce the use of animal-based assay testing for BOTOX® and BOTOX® Cosmetic by up to 95 percent or more over the next three years, as other regulatory agencies around the world approve this new assay. The new assay is the first to be developed and approved for any botulinum neurotoxin currently available worldwide, and is specifically applicable to Allergan’s botulinum toxin type A product.
“We are proud to have achieved this major scientific milestone in the development of a safe and effective alternative test capable of eliminating the need for an animal-based assay for BOTOX®,” said Scott Whitcup, M.D., Allergan’s Executive Vice President, Research and Development and Chief Scientific Officer. “Following the FDA approval, we will work hard to secure approval of the new assay to replace the current animal testing requirements for the release and stability testing of BOTOX® and BOTOX® Cosmetic in countries in which we market and distribute the product.”
Read the full original article at World Press Online at http://www.worldpressonline.com/PressRelease/allergan-receives-fda-approval-for-first-of-its-kind-fully-in-vitro-cell-based-assay-for-botox%C2%AE-and-botox%C2%AE-cosmetic-onabotulinumtoxina-30003.html