SKINVIVE by JUVÉDERM – P110033/S059
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: SKINVIVE by JUVÉDERM
PMA Applicant: Allergan Aesthetics
Address: 2525 Dupont Drive
Irvine, CA 92612 USA
Approval Date: May 11, 2023
Approval Letter: Approval Order
What is it?
SKINVIVE by JUVÉDERM is a gel implant or dermal filler that is injected in specific areas of facial tissue to add definition or reduce the appearance of lines and wrinkles. It consists of the chemical hyaluronic acid, 1,4-butanediol diglycidyl ether (BDDE), and 0.3% of the drug lidocaine to reduce pain on injection.
This approval expands the use of this product to include injections between the layers of the skin (intradermal) to improve the smoothness of the cheeks.
How does it work?
A doctor injects SKINVIVE by JUVÉDERM between the layers of skin (intradermally) in the face to produce the appearance of smoother skin.
When is it used?
SKINVIVE by Juvéderm injectable gel is indicated for intradermal injection to improve facial skin smoothness of the cheeks in people 21 years of age and older.
What will it accomplish?
When evaluated in a clinical study of 209 people, SKINVIVE by Juvéderm was found to be effective at improving facial skin smoothness in the cheeks. This effect lasted for at least six (6) months.
When should it not be used?
SKINVIVE by Juvéderm should not be used for people who have:
- Severe allergies with a history of anaphylaxis
- A history or known presence of multiple severe allergies
- A known sensitivity or allergy to gram-positive bacterial proteins
- Any known allergies to lidocaine
Additional information (including warnings, precautions, and adverse events):
- Summary of Safety and Effectiveness Data (SSED)
- Labeling (Clinician Labeling)
- Labeling (Patient Labeling)
- PMA Database Entry
- Dermal Fillers (Soft Tissue Fillers)