FDA accepts Dermik's supplemental PMA for alternative use of Sculptra

October 3, 2006

Washington - The Food and Drug Administration (FDA) has accepted for filing Dermik Laboratories' supplemental pre-market approval application (s-PMA) for Sculptra, an injectable poly-L-lactic acid, for facial cosmetic use.

Washington - The Food and Drug Administration (FDA) has accepted for filing Dermik Laboratories’ supplemental pre-market approval application (s-PMA) for Sculptra, an injectable poly-L-lactic acid, for facial cosmetic use.

Sculptra, marketed under the trade name NEW-FILL, was approved in Europe in 1999 to increase volume, particularly for the correction of skin creases, wrinkles, folds and scars, and was approved in the United States two years ago for treating lipoatrophy in HIV patients.