FDA Panel Recommends Lip Indication for Medicis’ RESTYLANE®

Posted: May 8, 2011 at 3:46 pm


FDA Panel Recommends Lip Indication for Medicis’ RESTYLANE®

SCOTTSDALE, Ariz. - Medicis (NYSE:MRX) Announced that the U.S. Food and Drug Administration’s (FDA) General and Plastic Surgery Devices Advisory Panel (the Panel) has recommended with a 6-0 vote (1 abstaining) that FDA expand the approved use of RESTYLANE® Injectable Gel, a hyaluronic acid dermal filler, to include lip augmentation. RESTYLANE is currently approved to treat moderate to severe facial wrinkles and folds, such as the lines from the nose to the corners of the mouth (nasolabial folds).

“We are pleased with the Panel’s recommendation to expand the RESTYLANE label to include lip augmentation,” said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. “RESTYLANE was the first hyaluronic acid dermal filler approved by FDA for use in the United States, and has played an instrumental role in the expansion and transformation of the U.S. dermal filler market since its launch in January 2004. We believe the Panel’s recommendation for label expansion reflects confidence in the robust clinical data provided by Medicis. If FDA follows the Panel’s recommendation, RESTYLANE could become the first and only hyaluronic acid dermal filler in the U.S. indicated for use in the lips.”

RESTYLANE is the most-studied aesthetic dermal filler in the world, and has been used in over 10 million treatments worldwide.1 Launched in the U.S. in January 2004 after approval by FDA on December 12, 2003, RESTYLANE was the first hyaluronic acid dermal filler approved in the U.S. Hyaluronic acid is a substance naturally present in the body. The hyaluronic acid in RESTYLANE closely resembles the body’s natural hyaluronic acid and is produced from a nonanimal source, making it free from animal protein, a quality which prevents disease transmission. Allergy pretesting is not necessary.

RESTYLANE has a unique gel particle structure designed for injection in the mid-to-deep dermis for structural support and lift, helping a patient look younger by smoothing away moderate to severe facial wrinkles and folds, such as nasolabial folds. RESTYLANE’s water-loving nature attracts and binds water molecules to help maintain volume.

RESTYLANE was shown to have an overall duration of effectiveness lasting up to 18 months from baseline following one repeat treatment at 4.5 or 9 months. RESTYLANE is injected into the tissue and will, in time, be resorbed by the body as the treatment results gradually wear off.

The complete RESTYLANE family of products currently approved for use in the U.S. by FDA includes RESTYLANE, RESTYLANE-L®, PERLANE® and PERLANE-L®. These products can be used individually to add volume and fullness to the skin to correct moderate to severe facial wrinkles and folds, such as nasolabial folds. Ask your healthcare professional which is right for you.

Important Safety Considerations for the RESTYLANE Family of Products
Products in the RESTYLANE family should not be used by people with previous bad allergies, particularly to certain microorganisms known as gram-positive bacteria, or by people with previous bad allergies to drugs that have required in-hospital treatment. These products should not be used by people with bleeding disorders. Injections should not be made anywhere except the skin or just under the skin. RESTYLANE-L injectable gel and PERLANE-L injectable gel should not be used by people with a known allergy to lidocaine.

Use of products in the RESTYLANE family at the site of skin sores, pimples, rashes, hives, cysts, or infection should be postponed until healing is complete. Use of the products in these instances could delay healing or make your skin problems worse. After your treatment, you might have some swelling, redness, pain, bruising, and tenderness. This will normally last less than seven days. In rare circumstances, the doctor may inject into a blood vessel, which can damage the skin. Although rare, red or swollen small bumps may occur. If you have had facial cold sores before, an injection can cause another outbreak. To avoid bruising and bleeding, you should not use the products if you have recently used drugs that thin your blood or prevent clotting. If you are pregnant, breastfeeding, or under 18 years, you should not use products in the RESTYLANE family.

Patients should be limited to 6.0 mL per treatment. The safety or effectiveness of products in the RESTYLANE family for the treatment of anatomic regions other than nasolabial folds have not been established in controlled clinical studies.

The RESTYLANE family of products is available only through a licensed practitioner. Complete product and safety information is available at http://www.RestylaneUSA.com.

About Medicis
Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and aesthetic conditions. The Company is dedicated to helping patients attain a healthy and youthful appearance and self-image. Medicis has leading branded prescription products in a number of therapeutic and aesthetic categories. The Company’s products have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance.

The Company’s products include the brands DYSPORT® (abobotulinumtoxinA) 300 Units for Injection, PERLANE® Injectable Gel, PERLANE-L® Injectable Gel with 0.3% Lidocaine, RESTYLANE® Injectable Gel, RESTYLANE-L® Injectable Gel with 0.3% Lidocaine, DYNACIN® (minocycline HCl Tablets, USP), LOPROX® (ciclopirox) Gel 0.77% and Shampoo 1%, SOLODYN® (minocycline HCl, USP) Extended Release Tablets, VANOS® (fluocinonide) Cream 0.1%, ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, AMMONUL® (sodium phenylacetate and sodium benzoate) Injection 10%/10%, BUPHENYL® (sodium phenylbutyrate) Tablets and Powder, the LIPOSONIX™ system2 and the over-the-counter brand ESOTERICA®.


Source: Medicis

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