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    Restylane Already Available Outside U.S.; Full Approval Expected

    WebMD Health News

    New Wrinkle Filler Gets FDA Panel Nod

    Nov. 20, 2003 -- Restylane, a new wrinkle filler, should get U.S. approval, an FDA advisory panel recommends.

    That's music to the ears of Rod J. Rohrich, MD, president of the American Society of Plastic Surgeons and chairman of the department of plastic surgery at University of Texas Southwest Medical Center in Dallas.

    "It is like youth in a syringe," Rohrich tells WebMD. "It's a synthetic version of a natural lubricating substance in our bodies. Using biotechnology, they harness this material in a syringe. You can plump up the areas where you age that make you look sad. Because as we age, our skin doesn't just sag -- it loses volume. This restores that volume."

    The panel's 6-3 vote comes with some conditions, an FDA spokesperson tells WebMD. The manufacturer has already agreed to some of these conditions. And as the FDA usually follows its panels' advice, full approval is expected in two or three months.

    The panel is also considering Hylaform, another new wrinkle filler already in use outside the U.S. Like Restylane, Hylaform is a hyaluronic acid gel. Restylane is fully synthetic; Hylaform comes from the combs of specially bred roosters.

    Restylane Can't Say It's Better -- Yet

    The panel's biggest restriction on Restylane is its refusal to allow the manufacturer to label the drug as superior to the collagen injections plastic surgeons now use to fill wrinkles. That decision was based on the clinical trial information the manufacturer submitted to the FDA.

    However, plastic surgeons are considerably more enthusiastic about both Restylane and Hylaform, Rohrich says. He notes that both products have an excellent safety record over eight to nine years in some 60 countries.

    "There has not been a substantial new filler in the U.S. in more than a decade," Rohrich tells WebMD. "This new set of fillers will be almost revolutionary. They last two to three times longer than the collagen-based fillers we now use."

    The panel's Restylane approval came with other restrictions:

    • Post-approval studies must be done to see whether Restylane works in people of color. Nearly all the people who took part in Restylane clinical trials were white.
    • Pending FDA consideration of these postmarketing studies, the label must carry a warning that there is limited data on its use in people of color.
    • Doctors must be educated in the use of Restylane before they can inject patients with it. Rohrich says the American Society of Plastic Surgeons is already planning to offer such training.
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