BOTOX® Cosmetic Consent Form

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BOTOX® Cosmetic: A Look at Looking Good
(July-August 2002, FDA Consumer Magazine - Excerpt)

BOTOX® was first approved in 1989 to treat two eye muscle disorders--uncontrollable blinking (blepharospasm) and misaligned eyes (strabismus). In 2000, the toxin was approved to treat a neurological movement disorder that causes severe neck and shoulder contractions, known as cervical dystonia. As an unusual side effect of the eye disorder treatment, doctors observed that BOTOX® softened the vertical frown (glabellar) lines between the eyebrows that tend to make people look tired, angry or displeased. But until this improvement was actually demonstrated in clinical studies, Allergan Inc., of Irvine, Calif., was prohibited from making this claim for the product.

By April 2002, the FDA was satisfied by its review of studies indicating that BOTOX® reduced the severity of frown lines for up to 120 days. The agency then granted approval to use the drug for this condition.

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BOTOX® Cosmetic Consent Form

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