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  1. www.news.sanofi.us › press-releasesFDA Approves Sculptra (R)Aesthetic, a Facial Injectable for ...

    BRIDGEWATER, N.J., July 29 / PRNewswire-FirstCall / -- Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) approved Sculptra Aesthetic (injectable poly-L-lactic acid) for the correction of shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial wrinkles which are treated with the ...

  2. en.wikipedia.org › wiki › SculptraSculptra - Wikipedia

    Sculptra. Sculptra is a proprietary formulation of poly- L -lactic acid (PLLA) that is an FDA -approved dermal filler manufactured by Dermik Laboratories, which conducts the American business of Aventis Dermatology, the global dermatology unit of Aventis (of Sanofi-Aventis ).

  3. www.galderma.com › news › galderma-receives-fda-approval-newGalderma Receives FDA Approval for New SCULPTRA® Label, ...

    2021年12月13日 · SCULPTRA is an injectable biostimulator containing microparticles of Poly-L-Lactic Acid (PLLA) which helps gradually revitalize the skin’s structural foundation, providing natural-looking, long-term results for up to 2 years*. 1-3 SCULPTRA was first approved for aesthetic use in 2009 in the United States and is currently available in more than 4...

  4. www.accessdata.fda.gov › cdrh_docs › pdf3Aesthetic - Food and Drug Administration

    Please direct any questions to sanofi-aventis U.S. LLC Bridgewater, NJ 08807; .1-800-633-1610 DEVICE DESCRIPTION SCULPTRA®Aesthetic is an injectable implant containing microparticles of poly-L-lactic acid (PLLA), carboxymethylcellulose (USP), non-pyrogenic mannitol (USP) and sterile water for injection (USP).

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  5. www.galderma.com › news › galderma-continues-global-growthGalderma continues global growth ambition with Sculptra® ...

    2021年3月4日 · Sculptra® is an injectable biostimulator containing microparticles of Poly-L-Lactic Acid (PLLA) which gradually revitalizes the skin’s structural foundation, providing natural-looking, long-term results for up to 25 months. Sculptra® was first approved in 1999 in Europe and it is currently available in more than 40 countries globally.

  6. www.fda.gov › recently-approved-devices › sculptra-p030050s039Sculptra – P030050/S039 | FDA

    2023年5月31日 · When is it used? This new approval establishes the use of Sculptra for correction of fine lines and wrinkles in the cheek region for people who are immune-competent. What will it accomplish?...