FDA Advisory Committee Unanimously Recommends JUVÉDERM VOLUMA™ XC as a Safe and Effective Treatment Option for Cheek Augmentation to Correct Age-Related Volume Deficit in the Mid-Face
IRVINE, Calif.--(BUSINESS WIRE)-- Allergan, Inc., (NYSE: AGN) is pleased that the U.S. Food and Drug Administration (FDA) General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee has voted unanimously that the benefits of JUVÉDERM 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, JUVÉDERM VOLUMA™ XC would be the first and only dermal filler in the United States with this indication.
"Today's recommendation is an important step in the FDA review process for JUVÉDERM VOLUMA™ XC," said Scott M. Whitcup M.D., Executive Vice President, Research and Development, Chief Scientific Officer, Allergan. "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."
The Advisory Committee's recommendation, although not binding, will be considered by the FDA when making the final approval decision for JUVÉDERM VOLUMA™ XC. If approved by the FDA, Allergan anticipates launching JUVÉDERM VOLUMA™ XC in late 2013.