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FDA Approves Asclera

FDA Approves Asclera to Treat Small Varicose Veins

ROCKVILLE, Md., March 30, 2010--The U.S. Food and Drug Administration today approved Asclera (polidocanol) injection for the treatment of small types of abnormally swollen or twisted veins called varicose veins.

Although they usually occur in the legs, varicose veins also can form in other parts of the body. Factors such as genetics, age, female gender, pregnancy, obesity, and prolonged periods of standing may increase the risk for varicose veins.

"Varicose veins are a common condition," said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products at the FDA’s Center for Drug Evaluation and Research. "Asclera is indicated for the treatment of small types of varicose veins when the aim of treatment is to improve appearance."

Asclera is approved to close spider veins (tiny varicose veins less than 1 millimeter in diameter) and reticular veins (those that are 1 to 3 millimeters in diameter). Asclera acts by damaging the cell lining of blood vessels. This causes the blood vessel to close, and it is eventually replaced by other types of tissue.

Common adverse reactions to Asclera include leakage and collection of blood from damaged blood vessels at the injection site (hematoma), bruising, irritation, discoloration, and pain at the injection site.

Asclera is distributed by BioForm Medical Inc. of Franksville, Wis., and manufactured by Chemische Fabrik Kreussler & Co. of Wiesbaden, Germany.

For more information:

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Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

Posted: March 2010

Asclera (polidocanol) FDA Approval History

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