
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.
"Today’s recommendation is an important step in the FDA review process for Juvederm Voluma XC," Allergan chief scientific officer and R&D executive vice president Dr. Scott Whitcup said in prepared remarks. "Allergan is committed to working with the FDA as they continue their review of our PMA for Juvederm Voluma XC, with the goal of providing consumers with the 1st treatment option that has been specifically developed to help restore cheek volume that has been lost over time."