RESTYLANE is the most-studied aesthetic dermal filler in the world, and has been used in over 10 million treatments worldwide. 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.

FDA Approves Lip Indication for Medicis' Restylane(R)

First and Only Hyaluronic Acid Dermal Filler Approved for Lips




Medicis (NYSE:MRX) announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval application (PMA) supplement to expand the approved use of RESTYLANE(R) Injectable Gel, a hyaluronic acid dermal filler, to include lip augmentation. RESTYLANE was previously 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). The new label will now include an indication for submucosal implantation for lip augmentation in patients over the age of 21. The RESTYLANE package insert will be amended to include the new indication, along with results from the clinical trials for lip augmentation. The Company anticipates using this information in its training and promotional activities.

"We are pleased with the FDA's decision to expand the RESTYLANE label to include lip augmentation," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "This marks another significant milestone for RESTYLANE, now the first and only hyaluronic acid dermal filler approved in the United States for lip augmentation. We were very encouraged by the compelling data from the robust pivotal clinical study, showing effectiveness for up to six months, with a clear majority of eligible subjects opting for retreatment at six months. We believe physicians and their patients will appreciate the unique gel particle structure of RESTYLANE and its ability to create fullness in the lips for up to six months."

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 the 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 in the nasolabial folds. RESTYLANE is injected into the tissue and will, in time, be resorbed by the body as the treatment results gradually wear off.

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.

More about MRX at www.Medicis.com.

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