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Allergan Inc Announces FDA Approval Of BOTOX Cosmetic (onabotulinumtoxinA) for Temporary Improvement Of Moderate To Severe Lateral Canthal Lines (Crow's Feet Lines) In Adults


Wednesday, 11 Sep 2013 09:07pm EDT 

Allergan Inc announced approval by the U.S. Food and Drug Administration (FDA) to market BOTOX Cosmetic (onabotulinumtoxinA), for an additional indication to temporarily treat moderate to severe lateral canthal lines, commonly known as 'crow's feet' lines. BOTOX Cosmetic is the first and only product of its kind approved for this indication. BOTOX Cosmetic, approved in the United States in 2002 for the temporary improvement of moderate to severe glabellar lines (frown lines between the brows) for patients aged 18 to 65 years, remains the number-one minimally invasive aesthetic medical treatment globally. The safety and efficacy of BOTOX Cosmetic as a treatment for crow's feet lines was demonstrated in two randomized, multi-center, placebo-controlled clinical trials. The studies enrolled more than 1,350 subjects with 833 subjects receiving treatment with BOTOX Cosmetic. The trial demonstrated that BOTOX Cosmetic was an effective treatment compared to the control group, which did not receive BOTOX Cosmetic treatment. 

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