Allergan receives new approvals for Botox and Vistabel assay

Allergan has hailed two positive new regulatory opinions received for the fully in-vitro cell-based assay it recommends for use in conjunction with its drugs Botox and Vistabel.

The Agence Francaise de Securite Sanitaire des Produits de Sante has approved the assay for use with Vistabel, which will support wider approval of the product in 29 countries across the EU.

Meanwhile, the Irish Medicines Board has given a positive view on the assay's use in conjunction with Botox, mirroring an earlier ruling for the UK by the Medicines and Healthcare Products Regulatory Agency.

It is thought that wider availability of the assay will improve stability and potency testing standards for the drugs, while also helping to reduce the use of animal-based assay testing.

Douglas Ingram, president of Allergan in Europe, Africa and the Middle East, said: "Along with the relevant European regulatory agencies, we are committed to securing national approvals and releasing the product using the new assay as rapidly as possible."

Earlier this month, the company published its 2011 financial results, highlighting a 7.2 percent annual growth rate.