Allergan Inc. (AGN) Thursday said advisers to the U.S. Food and Drug Administration recommended its dermal filler Juvederm Voluma XC.
The company said the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee has voted unanimously that the benefits of Juvederm Voluma XC, an injectable hyaluronic acid dermal filler for cheek augmentation to correct age-related volume deficit in the mid-face, outweigh the risks.
If approved, Juvederm Voluma XC would be the first and only dermal filler in the United States with this indication.
The Advisory Committee's recommendation, although not binding, will be considered by the FDA when making the final approval decision for Juvederm Voluma XC. If approved by the FDA, Allergan plans to launch the product in late 2013.
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