Juvéderm Voluma XC - P110033
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Juvéderm Voluma XC
PMA Applicant: Allergan
Address: 71 S. Los Carneros Rd., Goleta, CA 93117
Approval Date: October 22, 2013
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110033a.pdf
What is it?
Juvéderm Voluma XC is a sterile, biodegradable, viscoelastic gel implant. It consists of crosslinked hyaluronic acid produced by Streptococcus equi bacteria, formulated to a concentration of 20 mg/mL with 0.3% lidocaine.
How does it work?
Juvéderm Voluma XC is injected into facial tissue to temporarily restore volume and fullness to the areas of the mid-face, which include the cheeks and nearby regions confined to the middle portion of the face.
When is it used?
Juvéderm Voluma XC is used by a doctor in areas of the mid-face to correct age-related volume loss. The gel temporarily adds volume and fullness to the face in adults over the age of 21.
What will it accomplish?
Juvéderm Voluma XC temporarily reverses signs of age-related volume loss in the mid-face. In the clinical study, 86% of subjects had an improvement in their cheek fullness 6 months, and the results lasted up to 2 years in a majority of subjects. Most subjects also experienced moderate tenderness, swelling, firmness and/or lumps and bumps at the injection site which generally lasted 2 to 4 weeks.
When should it not be used?
Juvéderm Voluma XC should not be used in subjects who have:
- severe allergies manifested by a history of anaphylaxis
- history or presence of multiple severe allergies
- history of allergies to gram-positive bacterial proteins
- history of allergies to lidocaine
The Summary of Safety and Effectiveness Data and labeling are available.
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