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Botox to receive European approval for treatment of crow's feet

Botox set to receive European approval for treatment of crow’s feet

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23 October 2013
Botox set to receive European approval for treatment of crow’s feet

Following the US Food and Drug Administration’s (FDA) approval of Botox for the treatment of crow’s feet and wrinkles around the eyes, Allergan’s Vistabel (which is the same product as Botox but is the name given to it when used for cosmetic treatments) is set to receive European approval in 27 countries.

Vistabel received a positive opinion from the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM). A positive opinion is part of the approval process for Allergan to secure national licenses in the 27 countries in the European Union.

The European positive opinion for the use of Vistabel to treat crow’s feet lines is based on the results of two clinical studies involving more than 1,350 patients. Patients who received treatment with Vistabel achieved none or mild lines according to investigator assessment at day 30.

The FDA approval was the result of a study conducted by Allergan, which found that participants saw a greater reduction in crow’s feet after using Botox to treat the area.