Allergan Receives FDA Approval To Market JUVEDERM ULTRA XC For Lip Augmentation

(RTTNews) - Allergan plc, (AGN) announced that it has received approval from the U.S. Food and Drug Administration or FDA to market JUVEDERM ULTRA XC for injection into the lips and perioral area for lip augmentation in adults over the age of 21.

JUVEDERM ULTRA XC instantly adds fullness to the lips and is the only dermal filler that has proven results lasting up to one year for lip augmentation, the company said.

Since JUVEDERM formulations were first approved in the United States in 2006, physicians and patients have relied on them to correct moderate to severe facial wrinkles and folds, such as the parentheses lines around the nose and mouth. This heritage has continued with introduction of JUVEDERM VOLUMA XC for age-related mid-face volume loss in 2013, and now, with JUVEDERM ULTRA XC for lip augmentation.

In clinical trials of JUVEDERM ULTRA XC, the majority of subjects reported improvement in the softness, smoothness and natural look and feel of their lips through one year. In clinical trials, 79% of subjects showed a meaningful improvement in lip fullness three months after treatment. Additionally, more than 78% of subjects reported an improvement in their overall satisfaction with the look and feel of their lips at one year after treatment, according to the company.