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FDA Approves Juvéderm Volbella XC to Augment Lips

Allergan news release; 2016 Jun 1

The FDA has approved Juvéderm Volbella XC (hyaluronic acid; Allergan plc) for lip augmentation and for correction of perioral rhytids, commonly referred to as perioral lines, in adults over the age of 21. In clinical trials, Juvéderm Volbella XC was found to effectively increase lip fullness and soften the appearance of lines around the mouth.

Indications: Juvéderm Volbella XC is a gel designed to be injected into the lips in a physician’s office.

Dosage/administration: Juvéderm Volbella XC is injected into the lip and mouth area in a physician’s office. Results, in the majority of subjects in clinical trials, last through one year.

Adverse reactions: The most common side effects include swelling, tenderness, bruising, firmness, lumps/bumps, redness, pain, discoloration, and itching. Most side effects are mild or moderate and last 30 days or less. As with all skin injection procedures, there is a risk of infection.

Citation: Juvéderm Volbella XC approved by US FDA for use in lips and perioral rhytids. [news release]. Dublin, Ireland: Allergan plc; June 1, 2016: www.Juvederm.com. Accessed June 1, 2016.