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Allergan Announces FDA Approval of Label Extensions for
JUVÉDERM® Injectable Gel Ultra and JUVÉDERM® Injectable
Gel Ultra Plus Source: Allergan, Inc.
June 27, 2007
Only Hyaluronic Acid Dermal Fillers Approved To Last Up To 1 Year
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®
Injectable Gel Ultra and
JUVÉDERM®
Injectable Gel 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®
Injectable Gel Ultra and
JUVÉDERM®
Injectable Gel 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."
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