FDA Approves New Label for Injectable PLLA

The FDA announced a new label approval for an injectable poly-L-lactic acid (PLLA). The announcement expands on the PLLA’s current approval for treatment of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.

Particularly, the new label approval includes a higher dilution in addition to immediate use reconstitution, new injection techniques, and optional lidocaine. A recent randomized, evaluator-blinded, parallel-group, multicenter study evaluated the safety and effectiveness of two different dilutions of the injectable PLLA. The study found that the 9-mL higher reconstitution volume was well tolerated, even causing less pain with comparable wrinkle reduction as the 5-mL reference group.

"Aesthetic injectors will find that the higher reconstitution volume with optional lidocaine can help increase patient comfort, and the immediate use protocol provides greater convenience,” said Melanie Palm, MD, in the press release.

References
Galderma receives FDA approval for new SCULPTRA^® label, offering more options to aesthetic partners. Press release. Galderma; December 13, 2021. Accessed December 14, 2021. https://www.prnewswire.com/news-releases/galderma-receives-fda-approval-for-new-sculptra-label-offering-more-options-to-aesthetic-partners-301442450.html