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Allergan Announces Approval of Label-Extensions for Juvedermtm Ultra and Juvedermtm Ultra Plus
Only Hyaluronic Acid Dermal Fillers Approved To Last Up To 1 Year
(press Release From Allergan.com)
(IRVINE, Calif., June 26, 2007) – Allergan, Inc. (NYSE: AGN), the maker of BOTOX® Cosmetic (Botulinum Toxin Type A), today announced approval by the U.S. Food and Drug Administration (FDA) of label extensions for JUVÉDERM™ Ultra and JUVÉDERM™ Ultra Plus based on new clinical data demonstrating that the effects of both products may last for up to one year, which is longer than reported in clinical studies that supported FDA approval of other hyaluronic acid (HA) dermal fillers.
“Patients are looking for longer-lasting, science-based products that fill in lines, such as the parentheses around the mouth, as part of their overall anti-aging skin care regimen,” said Robert Grant, President of Allergan Medical, a division of Allergan. “We are pleased to provide physicians with the only HA dermal filler products currently approved in the United States to provide smooth, natural looking results lasting up to one year with a single treatment.”
Mark Pinsky, M.D., a West Palm Beach, Fla.-based plastic surgeon and a clinical investigator in the study that supported the label extensions, said, “The results of this study are exciting because they establish JUVÉDERM™ Ultra and JUVÉDERM™ Ultra Plus as the only HA dermal fillers approved on the market today to have proven persistence up to one year, which is an important attribute to patients. Most patients and physicians want fillers that are long-lasting and reversible – unlike semi-permanent or permanent products – because they provide a natural look that can be adjusted over time as the face changes.”
Important JUVÉDERM™ Dermal Filler Safety Information
JUVÉDERM™ is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds), and is generally well tolerated. In clinical studies, adverse events were usually mild to moderate in nature, did not require intervention and lasted seven days or less. The most common side effects included temporary injection site reactions including redness, pain/tenderness, firmness, swelling, lumps and bumps and bruising. For complete patient safety and prescribing information, please visit www.Juvederm.com .
Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading “Risk Factors” in Allergan’s 2006 Form 10-K and Allergan’s Form 10-Q for the quarter ended March 30, 2007. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.
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Copyright (2007) - Harold D. Clavin, M.D. - All Rights Reserved Clavin Center for Cosmetic and Plastic Surgery
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