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8/3/2004

Dermal Filler Approved for Facial Wasting

Kate Traynor

The Food and Drug Administration (FDA) announced today that it has approved the marketing of Sculptra, an injectable formulation of poly-L-lactic acid, to correct the facial wasting that results from a loss of subcutaneous fat in people infected with HIV.

According to FDA, Sculptra is the first product approved in this country to combat HIV-associated loss of fat from the cheeks, eyes, and temples. The agency stated that treatment of facial wasting has been found to improve the quality of life and to lessen anxiety in people with the condition.

Sculptra was not approved for cosmetic procedures such as wrinkle filling, according to FDA.

In clinical trials, patients received three to six injections of the product every two weeks. FDA noted that periodic additional treatments may be needed to maintain the product's effects.

Adverse events reported in clinical trials included redness, swelling, bruising, and nodule formation at the injection site. FDA stated that Sculptra should be administered only by health care providers who are familiar with the product's training materials and full package insert.

Sculptra is manufactured by Derwyn, Penn.-based Demmik Laboratories and sold in about 40 countries other than the United States, usually under the brand name New Fill.