FDA Approves Sculptra for Additional Cosmetic Use
Yesterday brought an exciting announcement from pharmaceutical company sanofi-aventis; Sculptra has been FDA cleared for physicians to use in additional facial cosmetic procedures. Even though off-label cosmetic use of Sculptra is common and has been happening for years, original approval of the filler was for treating lipoatrophy, i.e. facial fat loss, in AIDS patients. Professionals in the industry are excited to get official clearance for this long-lasting dermal filler.
The new FDA clearance specifies the following cosmetic purposes:
- Treatment of mild-severe nasolabial folds
- Treating 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.” No seriously adverse reactions to Sculptra occurred during the study.
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