Sculptra Gets Additional FDA Clearance

Posted on July 30, 2009 | by

Pharmaceutical company sanofi-aventis announced yesterday that federal clearance had been given to use Sculptra in facial 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. Professionals in the industry are excited to get official clearance for this long-lasting dermal filler.

The updated FDA clearance now specifies the following cosmetic purposes:

  1. Treatment of mild-severe nasolabial folds
  2. Treating Wrinkles and contour irregularities

Regulators based their evaluation of Sculptra on a study of 233 patients that had received treatment with the filler on nasolabial folds (smile lines). 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.

For more information about wrinkle filler treatment with Sculptra in Boston, contact us at Boston Plastic Surgery.