Allergan, Inc. (AGN) announced the U.S. Food and Drug Administration's approval of JUVEDERM XC, a new formulation of the currently FDA-approved JUVEDERM dermal filler and the latest advancement in hyaluronic acid, or HA, dermal fillers. Allergan's new JUVEDERM formulation contains the local anesthetic lidocaine to provide patients with enhanced comfort during treatment of moderate to severe facial wrinkles and folds, such as the nasolabial folds that appear around the nose and mouth.
The JUVEDERM XC formulation with 0.3% preservative-free lidocaine numbs the treatment area within seconds, potentially reducing the need for an additional anesthetic.
The company noted that the FDA approval of JUVEDERM XC was based on data from a multicenter, double-blind, randomized clinical trial. JUVEDERM XC was found to be more effective in reducing procedural pain during correction of facial wrinkles and folds while maintaining a similar safety and effectiveness profile to the non-lidocaine formulation of JUVEDERM.
Following FDA's approval, the new formulation of JUVEDERM with lidocaine is available for ordering nationwide.
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