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® VOLBELLA® XC
PMA Applicant: Allergan
Address: 2525 Dupont Drive, Irvine, CA 92612 USA
Approval Date: May 28, 2021
Approval Letter: Approval Order
What is it?
JUVÉDERM® VOLBELLA® XC is a gel implant (dermal or soft tissue filler) that is injected into specific areas of facial tissue. It consists of crosslinked hyaluronic acid made by a Streptococcal species of bacteria, formulated to a concentration of 15 mg/mL with 0.3% of the drug lidocaine as a numbing agent.
This product was previously approved for injection into the lips and skin around the lips to temporarily restore volume and fullness. This approval expands the use of this product to include use in the area under the eyes (infraorbital hollow) in adults over age 21.
How does it work?
JUVÉDERM® VOLBELLA® XC is injected by a doctor into the facial tissue to improve the appearance of darkness or hollowness under the eyes by temporarily adding volume or fullness.
When is it used?
This approval expands the use of JUVÉDERM® VOLBELLA® XC to include use in the infraorbital hollow for adults over age 21.
What will it accomplish?
JUVÉDERM® VOLBELLA® XC is intended to temporarily add fullness to the infraorbital hollow. In a clinical study, patients needed one or two treatments with multiple injections to achieve the best outcome. The results may last up to 12 months.
When should it not be used?
JUVÉDERM® VOLBELLA® XC should not be used in patients who have a history of:
- Severe allergies that lead to whole-body allergic reaction or anaphylaxis
- Multiple severe allergies
- Allergies to gram-positive bacterial proteins
- Allergy to lidocaine