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Author Topic: BOTOX: FDA approves Allergan's first in vitro, cell-based potency assay CBPA  (Read 9281 times)
Horst Spielmann
Free University Berlin, Professor for Regulstory Toxicology & retired from ZEBET at the Federal Ist for Risk Assessment
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« on: June 25, 2011, 12:36:15 pm »

On June 24, 2011, .Allergan, Inc. announced that 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.
For details please visit http://agn.client.shareholder.com/releasedetail.cfm?ReleaseID=587234

It is important that the new cell based assay will allow to replace the BOTOX LD50 test for both STABILITY and POTENCY testing.

It must be noted that the scientific basis of the CBPA (cell based potency assay) has not yet been disclosed by Allergan or the FDA. However, this is essential information, in order to replace LD-50  BoNT potency testing of other producers, who are not using BoNT-A toxin like Allergan but other BoNT toxins.  

Horst Spielmann  
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