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French Approval of Botox Injections
IRVINE, Calif. - Allergan Inc. said on Tuesday it had received approval by the French regulators for the use of its Botox wrinkle-fighting product in the treatment of frown lines between the eyebrows.
Botox will be marketed in France under the name Vistabel after the company said it received a nod from the Agence Francaise de Securite Sanitaire des Produits de Sante.
France will act as the Reference Member State in the mutual recognition process for this indication within the European Union, Allergan said.
The treatment will be used for Glabellar lines, which are formed by excessive contractions of two of the major muscles in the forehead, the corrugator and procerus.
This approved indication is now licensed for use in 19 countries including the United States, Canada, Australia, New Zealand and Switzerland, Allergan said.
The company is fighting a lawsuit filed in Los Angeles, California, alleging that Botox causes a chronic medical condition. The company said any side effects were temporary.
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