FDA panel deems Juvéderm Voluma safe for cheek augmentation

May 7, 2013

A Food and Drug Administration panel has recommended Juvéderm Voluma XC (hyaluronic acid, Allergan) as safe and effective to treat age-related volume loss in the mid-face.

 

A Food and Drug Administration panel has recommended Juvéderm Voluma XC (hyaluronic acid, Allergan) as safe and effective to treat age-related volume loss in the mid-face.

The FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee voted unanimously on the recommendation. If the FDA approves Voluma XC for cheek augmentation, it would be the first such dermal filler approved for this indication in the United States.

The advisory committee’s recommendation is not binding but will be considered by the FDA when it makes its final decision about Voluma XC. If approved, Allergan expects to launch the product late this year.

“Allergan is committed to working with the FDA as they continue their review of our PMA for Juvéderm Voluma XC, with the goal of providing consumers with the first treatment option that has been specifically developed to help restore cheek volume that has been lost over time,” Scott Whitcup, M.D., Allergan’s executive vice president of research and development, stated in a news release.