Yes, Sculptra is FDA approved. The product—poly-L-lactic acid (PLLA) microparticles suspended in carboxymethylcellulose—received FDA clearance in 2004 for correction of shallow to deep nasolabial folds and other facial wrinkles in immunocompetent patients. In 2009, the indication expanded to include correction of signs of facial lipoatrophy in HIV-positive patients. Sculptra remains the only FDA-cleared PLLA biostimulator for facial aesthetic use in the United States, and it is manufactured by Galderma.
Injectables
Is Sculptra FDA Approved? Status, Indications, and Clinical Use
Sculptra holds FDA clearance for specific facial indications and is the market-leading PLLA biostimulator—but approval scope matters for your practice.
