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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

cial aging," said Paul Chew, M.D., Chief Science Officer/Chief Medical Officer, sanofi-aventis U.S.

No serious adverse events were reported in this study for either treatment. Commonly occurring short-term injection site reactions were bleeding, tenderness or pain/discomfort, redness, bruising, itching or swelling and were reported in both treatment groups. Other adverse events reported during the 25 month trial included small bumps and lumps, some with a delayed onset and were mild or moderate in intensity. Most side effects resolved on their own; one small lump required treatment by the healthcare provider.

US.POL.08.09.005

Important Safety Information:

You should not use Sculptra Aesthetic if you are allergic to any ingredient of the product or have a history of keloid formation or hypertrophic scarring. Sculptra Aesthetic should not be injected while you have an active skin infection or inflammation in the treatment area and should not be injected into the red area of the lip. Use in the skin near the eyes is not recommended.

Side effects of Sculptra Aesthetic may include injection site discomfort, redness, bruising, bleeding, itching and swelling. Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area. Larger lumps, some with delayed onset with or without inflammation or skin discoloration, have also been reported. In a key clinical study the numbers of small and larger lumps were low and most resolved without treatment.

For more information, including full Prescribing Information, please visit www.SculptraAesthetic.com or www.sanofi-aventis.us.

About sanofi-aventis

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