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New Device Approval

Restylane™ Injectable Gel - P020023

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Restylane™ Injectable Gel
Applicant: Q-Med Scandinavia, Inc.
Address: 2325 Dulles Corner Boulevard, Suite 500, Herndon, VA 20171
Approval Date: December 12, 2003
Approval Letter: http://www.fda.gov/cdrh/pdf2/P020023a.pdf

What is it? Restylane™ is a transparent hyaluronic acid gel that is injected into facial tissue to smooth wrinkles and folds, especially around the nose and mouth (nasolabial folds). Hyaluronic acid is a substance that is produced naturally by the body.

How does it work? Restylane™ works by temporarily adding volume to facial tissue. The effect lasts for about 6 months.

When is it used? Restylane™ is injected by a doctor into areas of facial tissue where moderate to severe facial wrinkles and folds occur.

What will it accomplish? Restylane™ will help smooth moderate to severe facial wrinkles and folds. In a clinical study most patients needed one injection to achieve optimal wrinkle smoothing; about one-third of patients needed more than one injection to get a satisfactory result. The smoothing effect lasted about six months.

Side effects of Restylane™ include:

• bruising,
• redness,
• swelling,
• pain,
• tenderness, and
• itching.

When should it not be used?

Restylane™ should not be used in patients who have:

• severe allergies marked by a history of anaphylaxis (hypersensitivity to the ingestion or injection of a drug or protein),
• multiple severe allergies,
• severe allergies to gram-positive bacterial proteins,

Restylane™ should not be used for:

• breast augmentation,
• implantation into bone, tendon, ligament, or muscle, or
• implantation into blood vessels, because it may obstruct blood flow.

Additional information:

Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf2/p020023.html

Other:

• 2003 FDA talk paper “FDA Approves New Product for Facial Wrinkles”: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01271.html

Updated January 20, 2004

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