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Botox Cosmetic granted regulatory approval in France

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IRVINE, Calif. — Botulinum toxin type A has been granted regulatory approval in France for the treatment of glabellar lines, according to developer Allergan. The drug, marketed as Botox in the United States, will be marketed as Vistabel in France and Europe, a company press release indicated.

Glabeller lines are vertical frown lines that occur between the eyebrows, formed by excessive contractions of two of the major muscles in the forehead. The drug works by relaxing those affected muscles and blocking the nerve impulses that trigger the wrinkle-causing contractions. A 12-month repeated treatment study in the United States and Canada indicated that 80% of patients treated with the drug experienced maximum effect after 30 days. After two additional injections, the maximum reduction of glabellar lines was achieved in 89% of patients.

According to Allergan, France will be used as the reference member state within the European Union in the mutual recognition process of this indication.