IRVINE, CA, USA I May 3, 2013 I 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.
About Allergan
Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential. Today, we have approximately 11,100 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work. For more information regarding Allergan, go to: www.allergan.com.
SOURCE: Allergan
Post Views: 138
IRVINE, CA, USA I May 3, 2013 I 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.
About Allergan
Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential. Today, we have approximately 11,100 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work. For more information regarding Allergan, go to: www.allergan.com.
SOURCE: Allergan
Post Views: 138
