JUVÉDERM® VOLUMA™ XC – P110033/S047
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: 2525 Dupont Drive, Irvine, CA 92612
Approval Date: June 12, 2020
Approval Letter: Approval Order
What is it? JUVÉDERM® VOLUMA™ XC is a gel implant (dermal filler) that is injected into specific areas of facial tissue. It consists of crosslinked hyaluronic acid (HA) made by the Streptococcus species of bacteria, formulated to a concentration of 20 mg/mL with 0.3% of the drug lidocaine as a numbing agent.
This product was previously approved for injection into facial tissue to temporarily restore volume and fullness to the areas of the mid-face, which includes the cheeks and nearby regions confined to the middle portion of the face. This approval expands the use of this product to include the chin region.
How does it work? A doctor injects JUVÉDERM® VOLUMA™ XC into the facial tissue of the patient’s mid-face (which includes the cheeks and nearby regions confined to the middle portion of the face) and/or the chin to temporarily add volume and fullness.
When is it used? JUVÉDERM® VOLUMA™ XC, with this expanded approval, may also be used in adults aged 22 and older to temporarily improve the volume of the chin.
What will it accomplish? JUVÉDERM® VOLUMA™ XC is intended to temporarily add fullness to the patient’s mid-face (which includes the cheeks and nearby regions confined to the middle portion of the face) and/or the chin. In a clinical study, 56% of subjects had an improvement in their chin profile at 6 months.
When should it not be used? JUVÉDERM® VOLUMA™ XC should not be used in patients who have a:
- history of severe allergies that leads to whole-body allergic reaction or anaphylaxis
- history or presence of multiple serious allergies
- history of allergies to gram-positive bacterial proteins
- history of allergies to the drug lidocaine
Additional information (including warnings, precautions, and adverse events):