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Restylane

The following article is excerpted from a report about FDA approval of Restylane in the Wall Street Journal (December, 2003):

A new Botox competitor to fill in facial wrinkles has federal approval, which is good news for patients who have been traveling to Canada or Europe for the treatments.

Restylane, an injectable treatment from Medicis Pharmaceutical Corp., Scottsdale, Arizona, won approval by the Food and Drug Administration last month, three weeks after a panel of plastic-surgeon experts supported the product. Restylane has been regulated for use in Europe since 1996.

Unlike Botox, an injection that temporarily deadens nerve cells to unfurrow brows, Restylane plumps up wrinkles to fill them in. The FDA said the company's studies showed Restylane works and is safe on the nasolabial fold, the wrinkle from nose to mouth. Made from hyaluronic acid, the product's antiwrinkle power lasts about six months, after which it is absorbed into tissue ...

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The FDA isn't requiring allergy skin tests before Restylane is used, giving the new product an advantage over collagen. Collagen injections, which are also approved for filling wrinkles, accounted for 450,000 cosmetic procedures last year ... Medicis says typical Restylane treatments will run between $400 and $800.

Another hyaluronic-acid injection - Hylaform from Genzyme Corp., to be sold by Inamed Medical Corp., -- won a positive panel vote the same day as Restylane, but hasn't yet received FDA approval. The agency typically heeds the advice of its panel of outside experts.

 

The Shape of Things to ComeCopyright Dr. Scott J. Zevon, Board Certified Plastic Surgeon of New York City at Central Park Plastic Surgery
The Shape of Things to Come with Plastic Surgery - Dr. Scott Zevon, Board Certified Plastic Surgeon of New York City at Central Park Plastic Surgery

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