Galderma’s new SCULPTRA® Label, the first and only FDA-approved PLLA facial injectable treatment

Galderma announces the new label for SCULPTRA® (injectable poly-L-lactic acid (PLLA)), the first and only FDA-approved PLLA facial injectable treatment that helps stimulate the skin’s own collagen production, to smooth facial wrinkles, such as smile lines.

The new label is approved by the US Food and Drug Administration (FDA) includes higher dilution, the addition of immediate use reconstitution, new injection techniques and the optional addition of lidocaine. These changes provide aesthetic injectors with even more options to administer SCULPTRA safely and effectively .The new label approval is based on new data from physiochemical studies, as well as results from a randomised, evaluatorblinded, parallel-group, multi-centre study evaluating the safety and effectiveness of two different dilutions of SCULPTRA. It delivers gradual, natural-looking results over an average of three treatments spaced at least three weeks apart. This new label is just one example of how they continue to invest in their portfolio to ensure our healthcare partners have the products they need and Galderma is committed to driving innovation in aesthetics. SCULPTRA is an important part of Galderma’s collection of aesthetic treatments in the US, and this new label will allow in improving the overall injector and patient experience. Aesthetic partners will learn about the new label, train on injection technique, and share best practices through the Galderma Aesthetic Injector Network (GAIN) training and education platform, for incorporating SCULPTRA into their aesthetic offering.