Press release from Business Wire
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
Thursday, May 02, 2013
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-Face16:53 EDT Thursday, May 02, 2013
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.
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.
This press release contains "forward-looking statements," including the statements by Dr. Whitcup, and other statements regarding the potential FDA approval and product launch of JUVÉDERM VOLUMA™ XC. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; challenges related to achieving regulatory approval from the FDA on a timely and cost-efficient manner; technological advances and patents attained by competitors; inconsistency of treatment results among patients; potential difficulties in manufacturing; challenges related to new product marketing, such as the unpredictability or market acceptance for new products and/or the acceptance of new indications for such products; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risks can be found in press releases issued by Allergan, as well as Allergan's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. Copies of Allergan's press releases and additional information about Allergan are available at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.
©2013 Allergan, Inc. Irvine, CA 92612. ® and ™ marks owned by Allergan, Inc.
Bonnie Jacobs (856) 912-9965; (714) 246-5134 (media); Jacobs_bonnie@allergan.com
Lanie Shapero (732) 991-4368; (908) 203-2631 (media); Shapero_lanie@allergan.com
Jim Hindman (714) 246-4636 (investors)
Joann Bradley (714) 246-4766 (investors)
David Nakasone (714) 246-6376 (investors)