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FDA Approves Allergan's Cell-based Assay for Botox

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Allergan announced late on Friday that the US Food and Drug Administration has approved its in vitro, cell-based assay for use in the stability and potency testing of Botox and Botox Cosmetic, possibly eliminating the need for animal-based testing of the treatment.

The approved assay will be used immediately on Botox products sold in the US, Allergan said. It added that as other regulatory agencies worldwide approve the assay, it could reduce the use of animal-based testing for Botox products by up to 95 percent or more during the next three years.

The 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.

"Following the FDA approval, we will work hard to secure approval of the new assays 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," Scott Whitcup, Allergan's executive vice president of R&D and chief scientific officer, said in a statement.

Approval of the assay by FDA follows more than a decade of R&D at Allergan and an investment of about $65 million to minimize the need for animal-based testing for Botox products, the company said.

"The new cell-based potency assay we have developed for Botox and Botox Cosmetic has many advantages over current methods, including the potential for greater precision and consistency in stability and potency testing, making this a significant breaththrough in both the science and manufacturing of neurotoxins," said Timothy Terrell, senior vice president of drug safety evaluation for Allergan.

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