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 JUVEDERM VOLUMA(TM) 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(TM) 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 JUVEDERM VOLUMA(TM) 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 JUVEDERM VOLUMA(TM) 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 JUVEDERM VOLUMA(TM) XC. If approved by the FDA, Allergan anticipates launching JUVEDERM VOLUMA(TM) XC in late 2013.
What a bonanza! This is a ground-breaking and game-changing product for the Facial Aesthetic sector.
it the first of it's kind to come to market.
Allergan's competitors have much to be concerned about with this news.
One day after being knocked down, AGN get's up and throws down this gem.
What a great company!