Botox Granted Cosmetic License for Glabellar Lines

Allergan, the manufacturers of Botox®, were granted a license to promote the product for the treatment of glabellar lines on 30th November 2011.

This may sound strange, as Botox® has been used for frown lines and wrinkles in the UK since 1994 – although technically it has been unlicensed for this cosmetic indication until now.

A licensed version of botulinum toxin for Glabellar lines containing exactly the same product has been marketed under the brand name Vistabel® by Allergan since 2006 and has been available in 50 unit vials only. Both Botox® and Vistabel® are Allergan's brands of botulinum toxin type A, a purified protein derived from the bacterium Clostridium botulinum.

Health authorities in some countries, which have included until recently the MHRA in the UK, require that Botox® for cosmetic use be renamed to clearly distinguish between therapeutic and cosmetic use of the product.

With dosing specific to treat frown lines between the brows, Botox® for cosmetic use is now marketed as Botox® Cosmetic in the U.S. and Canada; and until recently as Vistabel® in the UK, France, Spain, Switzerland and many other EU countries; and as Vistabex™ in Italy.

Although many consumers visiting clinics looking for treatment of frown lines may ask for Botox – in practice, they may actually receive competing brands of botulinum toxin, which are also licensed for glabellar lines injections. These include Azzalure (promoted by Galderma) and Bocouture (promoted by Merz). In addition – it is also possible that they will receive the same respective unlicensed versions of these toxins – Dysport (Ipsen) and Xeomin (Merz).

With Botox® receiving a license for a cosmetic indication, some 17 years after its launch in the UK, it finally allows Allergan to promote their most well known of cosmetic brand names unhindered direct to cosmetic clinics and practitioners without contravening strict Medicines promotions guidelines enforced by the MHRA.