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

New Wrinkle Filler Gets FDA Panel Nod

Bottom Line: Technique continued...

Because Hylaform clinical trials excluded people allergic to birds -- Hylaform is made from rooster combs -- doctors must find out whether patients have bird allergies. They can do this either by skin testing or by confirming the patient has no history of such allergies.

The panel also recommended that the Hylaform label state that the product's safety and efficacy data is based on only one injection. Multiple injections will be needed to maintain the Hylaform's cosmetic effect. It's not clear what effect this recommendation will have.

According to Genzyme, the product's manufacturer, more than half a million doses of Hylaform have been safely used in Europe since its approval there in 1995.

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