FDA approves new Medicis wrinkle treatment

Medicis Pharmaceutical Corp., a Scottsdale-based independent specialty pharmaceutical company, has won U.S. Food and Drug Administration approval to sell an injectable gel for temporarily filling facial wrinkles.

Restylane is an injection for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, the lines between the nose and mouth. Restylane is the first and only FDA-approved dermal filler made of a biodegradable nonanimal stabilized hyaluronic acid, the company stated in a written release late Friday. Hyaluronic acid is a natural substance found in all living organisms and provides volume and fullness to the skin.

"The approval of Restylane is not only a very important milestone in the history of Medicis, but also represents a significant advance in cosmetic dermal fillers," said Jonah Shacknai, chairman and chief executive of Medicis. "With its proven track record for long-lasting efficacy and safety in more than 1 million procedures worldwide, we believe that Restylane will set a new standard for noninvasive cosmetic procedures."

Restylane is formulated as a clear gel and uses a dual mechanism of action to correct wrinkles and folds. Upon being injected beneath the skin's surface, the gel adds natural volume and lift to smooth wrinkles and folds.

Restylane gradually degrades over time and disappears without any residue, usually about six months or longer after the injection.

Medicis Aesthetics Inc., the company that is marketing and selling Restylane in the United States, is a wholly-owned subsidiary of Medicis Pharmaceutical Corp., an independent specialty pharmaceutical company in the United States focusing primarily on the treatment of aesthetic, dermatological, pediatric and podiatric conditions.

For more: www.restylaneusa.com