News Postings
Allergan Receives Positive Opinions for Fully In Vitro, Cell-Based Assay for BOTOX and VISTABEL
- Type: News
- Published: 2012-02-23
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Allergan is pleased to announce the company has received two positive opinions regarding its fully in vitro, cell-based assay for use in the stability and potency testing of BOTOX(R) and VISTABEL(R) (Allergan's botulinum toxin type A products). he first positive opinion, from Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), relates to VISTABEL(R) and paves the way for approval in 29 countries in the European Union. The second positive opinion was granted by the Irish Medicines Board (IMB) for BOTOX(R) and covers 14 European Union countries involved in the Mutual Recognition Process. The Medicines and Healthcare products Regulatory Agency (MHRA) have already approved the assay for BOTOX(R) vials sold in the UK. Once approval is finalized, the new assay will be utilized to release the product for sale in the relevant countries.