WHAT DOES FDA APPROVAL MEAN?

You've heard it many times before: A product is advertised as "FDA-approved." But what does that really mean?
In the United States, prescription drugs and biologics are required to undergo rigorous laboratory, animal, and human clinical testing before they can be put on the market. The Food and Drug Administration (FDA) reviews the results of these studies to:

• verify the identity, potency, purity, and stability of the "ingredients," and
• demonstrate that the drug is safe and effective for its intended use.

What about BOTOX® Cosmetic?

BOTOX® Cosmetic received FDA approval in 2002 for the temporary treatment of moderate to severe frown lines between the brows in people 18 to 65 years of age. BOTOX® Cosmetic is available by prescription only.

Close Window