12.09.2013 07:58:33

Allergan Says FDA Approves Botox Cosmetic For Crow's Feet

(RTTNews) - Allergan, Inc. (AGN) Wednesday said that the U.S. Food and Drug Administration has approved 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. It was approved in the U.S. in 2002 for the temporary improvement of moderate to severe frown lines between the brows for patients aged 18 to 65 years and remains the number-one minimally invasive aesthetic medical treatment globally.

Scott Whitcup, Chief Scientific Officer, Allergan, said, "... With this approval, BOTOX Cosmetic is now the only pharmaceutical approved to treat both crow's feet lines and frown lines between brows. This approval will enhance our ability to work with and train aesthetic physicians on the science of administering BOTOX Cosmetic to yield the best possible outcomes for patients."

The safety and efficacy of Botox Cosmetic, a prescription medication, as a treatment for crow's feet lines was shown in two randomized, multi-center, placebo-controlled clinical trials that enrolled over 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 the treatment.

AGN closed down 1.2 percent at $87.75 on Wednesday.

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