Allergan Inc has announced the 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.

According to a company press release, 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% 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.


[Source: Marketwatch]