FDA and FFDCA approval is based on the review of data collected from controlled clinical studies that evaluated the safe and effective use of the wrinkle fillers when injected into specified areas of facial tissue.
More information about the FDA approval is based on the review of data collected from controlled clinical studies that evaluated the safe and effective use of the dermal fillers when injected into specified areas of facial tissue.
The Summary of Safety and Effectiveness Data for each approved dermal filler contains links to additional information about the clinical data the FDA reviewed. Links to this information can be found under the “Trade Name” column in the table below. This table lists all FDA-approved dermal fillers. It should be noted that not all of the dermal fillers listed below are currently marketed.
Trade Name (with link to additional information)Decision DateRESTYLANE SILK6/13/2014JUVEDERM VOLUMNA XC10/22/2013
8/30/2012BELOTERO BALANCE11/14/2011RESTYLANE INJECTABLE GEL10/11/2011SCULPTRA AESTHETIC7/28/2009EVOLENCE COLLAGEN FILLER6/27/2008PREVELLE SILK2/26/2008RADIESSE 1.3CC AND 0.3CC12/22/2006RADIESSE 1.3CC AND 0.3CC12/22/2006ELEVESS12/20/2006ARTEFILL10/27/2006
additional information)Decision DateJUVEDERM 24HV, JUVEDERM 30, and JUVEDERM 30HV6/2/2006RESTYLANE INJECTABLE GEL3/25/2005CAPTIQUE INJECTABLE GEL11/12/2004SCULPTRA8/3/2004HYLAFORM (HYLAN B GEL)4/22/2004RESTYLANE INJECTABLE GEL12/12/2003COSMODERM 1 HUMAN-BASED C3/11/2003FIBREL2/26/1988ZYPLAST(R)6/24/1985ZYDERM COLLAGEN IMPLANT9/18/1981
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