A year ago Horst Spielmann and I posted messages about Allergan's development of a cell-based assay for assessing the potency of Botox, a neurotoxin-based product used for cosmetic and medical purposes. This would replace the LD50 test in mice for this purpose. At the time of its announcement, Allergan had gained regulatory approval for the new assay in the United States. The challenge then was to gain regulatory approval in other markets. A recent news item in the journal Altex by Silke Bitz provides an update on recent regulatory approvals of this assay in Europe--specifically Switzerland and "favorable opinions" in France and Ireland (http://www.altex.ch/en/index.html?id=17&ncat=1&nid=219
). The latter two countries have mutual recognition agreements with many other European countries, which bodes well for a broad-based international acceptance.
Does anyone have an update on the progress of other manufacturers of botulinum neurotoxin-based products in replacing the LD50 test?