FDA expands Sculptra label

The FDA has approved a new label for Galderma’s facial injectable Sculptra that adds new options for clinicians, the company announced in a press release.

Sculptra (injectable poly-L-lactic acid), smooths facial wrinkles by stimulating the skin’s own collagen production.

The new label includes higher dilution, an addition of immediate use reconstitution, new injection techniques and the option to add lidocaine.

“Galderma is committed to driving innovation in aesthetics, and the new label for Sculptra is just one example of how we continue to invest in our portfolio to ensure our health care partners have the products they need,” Diane Gomez-Thinnes, head of Galderma U.S., said in the release. “Interest in biostimulators is growing, and we are committed to continuing our legacy of training and education, focused on safety and outcomes as a part of our overall commitment to the aesthetic industry.”

The approval was based on data from studies that evaluated the safety and effectiveness of two different Sculptra dilutions.