Monday, multi-specialty health care company Allergan, Inc. (AGN) announced that the U.S. FDA has approved its new formulation Juvederm XC, an anti-wrinkle dermal filler that is an improvement of its earlier FDA-approved Juvederm.
Allergan's new Juvederm XC formulation, used for treatment of moderate to severe facial wrinkles and folds, contains the local anesthetic Lidocaine, reducing the need for an additional anesthetic. The new Juvederm XC formulation also has a shorter treatment duration than the earlier Juvederm.
The FDA approval of Juvederm XC is based on data from a multicenter, double-blind, randomized clinical trial, observing 72 subjects. In the clinical study, 93% patients reported less pain when treated with the new formulation Juvederm XC, compared to those treated with the non-Lidocaine formulation of Juvederm. Juvederm XC was also 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 earlier dermal filler.
Following FDA approval, the company said that Juvederm XC with Lidocaine is available for ordering in the U.S.
AGN is currently trading at $57.51, up $0.01 or 0.02%, on the NYSE.
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