FDA Panel Votes in Favor of Allergan Inc.'s Juvederm Voluma XC Facial Filler

Published: May 03, 2013

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The FDA's General & Plastic Surgery Devices advisory panel votes unanimously that the benefits outweigh the risks for aesthetic medical device maker Allergan's Juvederm Voluma XC injectable gel. An FDA advisory panel voted today to recommend approval for Allergan's (NYSE:AGN) Juvederm Voluma XC dermal filler for aesthetic volume restoration in the mid-face. The FDA's General & Plastic Surgery Devices advisory panel unanimously decided that the injectable gel is safe, effective and that its benefits outweigh its risks. Although facial fillers are already used off-label for age-related volume deficit in the mid-face, it would be a regulatory 1st if the FDA followed the panel's recommendation in approving Juvederm Voluma XC with that indication.

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