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Article

April 1, 2004

FDA panel recommends Sculptra to treat HIV-related lipoatrophy

Gaithersburg, Md. - The FDA General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting on March 25 unanimously recommended approval of Sculptra for reconstructive purposes with lipoatrophy associated with HIV infection and treatment. However, because of limited clinical data and fear of off-label use, the panel recommended attaching five conditions to that approval.