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Clarity on Cosmetic Injectable Labeling and Use
Date:4/14/2008

NEW YORK, April 14 /PRNewswire-USNewswire/ -- When it comes to cosmetic injectables, the terms "investigational" and "off-label" are often used interchangeably, often confusing consumers. The Physicians Coalition for Injectable Safety offers consumers these guidelines and definitions:

"A label containing specific consumer safety information is required by the Food and Drug Administration after a drug or medical device has been approved," explained Coalition leader Roger Dailey, MD of Portland, OR. "There are very specific labeling requirements including things such as brand name, drug content, the indications for a drug or device, dosing, adverse reactions, warnings and even data obtained from clinical studies."

A label defines the specific use for which a drug has been approved. "Off-label use refers to the legal practice of prescribing a drug for a purpose other than its stated indication; this is up to your doctors' discretion and is commonly done, however it is illegal for a manufacturer to market, advertise or otherwise promote the off-label use of drugs," said Coalition member Mark A. Codner, MD of Atlanta, GA. "For example, most dermal fillers are specifically approved for use in the nasolabial folds, the creases that run from the outer corner of the nose to the outer corner of the mouth. As a result, other forms of tissue enhancement that are commonly addressed with dermal fillers are considered 'off-label' as these specific treatments were not part of the clinical data submitted for approval," he continued.

"The term investigational means that either a drug or device is being studied in a particular application as part of the process necessary to submit for approval to the U.S. FDA, or that an approved drug or device is being studied for new uses," explained Dr. Dailey. "For example, consider that Botox(R) is approved for many clinical applications and Botox(R) Cosmetic is approved for cosmetic use. However, there is no app
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SOURCE Physicians Coalition for Injectable Safety
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