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FDA Approves Sculptra(R)Aesthetic, a Facial Injectable for Correction of Nasolabial Folds and Other Facial Wrinkles
Date:7/29/2009

BRIDGEWATER, N.J., July 29 /PRNewswire-FirstCall/ -- Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) approved Sculptra(R)Aesthetic (injectable poly-L-lactic acid) for the correction of shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial wrinkles which are treated with the appropriate injection technique in healthy patients. Sculptra(R)Aesthetic works gradually to offer natural-looking results that can last up to two years.

"We are excited by the FDA approval of Sculptra(R)Aesthetic because it changes the landscape of what physicians can offer patients seeking natural and gradual looking results from an aesthetic injectable that is long-lasting," said Doris Day, M.D., Clinical Assistant Professor of Dermatology at New York University and in private practice in New York City. "Sculptra(R)Aesthetic allows for a natural correction."

The FDA approval of Sculptra(R)Aesthetic is based on results from a randomized, comparative, evaluator-blinded, parallel group, multi-center study of 233 patients. Patients received Sculptra(R)Aesthetic or an approved human derived collagen for the treatment of their nasolabial fold wrinkles.

Sculptra(R)Aesthetic was administered in a single treatment regimen, at three week intervals, for up to 4 treatment sessions for the correction of shallow to deep nasolabial fold contour deficiencies using a deep dermal grid pattern (cross-hatch) injection technique. The Sculptra(R)Aesthetic patients were followed for an additional 12 months. Sculptra(R)Aesthetic treatment effects were maintained up to 25 months after the last treatment session, while the human derived collagen was effective up to 3 months.

"Sculptra(R)Aesthetic showed effective correction of the nasolabial folds, which are considered to be the hallmark signs of fa
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SOURCE sanofi-aventis
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