Company spokespersons from pharmaceutical company sanofi-aventis announced yesterday that federal clearance had been given to use their dermal filler Sculptra in cosmetic procedures. Although (off-label) cosmetic use of Sculptra has been happening for years, the original FDA approval of Sculptra was for treating lipoatrophy, i.e. facial fat loss, in AIDS patients. People in the industry are excited to get official clearance for this long-lasting dermal filler.
The Food and Drug Administration gave clearance for the following cosmetic purposes:
- Correction of mild-severe nasolabial folds
- Wrinkles and contour irregularities
Regulators based their evaluation of Sculptra on a study of 233 patients that had received treatment with the filler for their nasolabial folds. According to the official press release, the aesthetic results of Sculptra “were maintained up to 25 months after the last treatment session.”
