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6/26/2007 -- ALLERGAN ANNOUNCES FDA APPROVAL OF LABEL EXTENSIONS FOR JUVÉDERM™ ULTRA AND JUVÉDERM™ ULTRA PLUS
Only Hyaluronic Acid Dermal Fillers Approved To Last Up To 1 Year
(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.
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5/2/2007 -- MEDICIS ANNOUNCES FDA APPROVAL OF PERLANE PERLANE's Larger Hyaluronic Acid Gel Particles are Designed to Provide Volume and Lifting Power for Effective Facial Wrinkle and Fold Correction
SCOTTSDALE, Ariz., May 2, 2007 (PRIME NEWSWIRE) -- Medicis (NYSE:MRX) today announced that the U.S. Food and Drug Administration ("FDA") has approved the dermal filler PERLANE® for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds. PERLANE® is the newest member of the RESTYLANE® family of products and, like RESTYLANE®, PERLANE® is comprised of biotechnologically engineered, non-immunogenic, stabilized hyaluronic acid gel particles, and has patent protection until at least 2017. The primary difference between RESTYLANE® and PERLANE® is that the hyaluronic acid gel particles in PERLANE® are larger than those found in RESTYLANE®. PERLANE® is intended to be implanted into the deep dermis to superficial layer of the subcutis to add volume to restore surface contour in facial wrinkles and folds. The three-dimensional gel particles in RESTYLANE® and PERLANE® are hydrophilic molecules, attracting and binding to water molecules as they degrade, helping to maintain volume augmentation for about six months. Also distinct from other hyaluronic acid dermal fillers, RESTYLANE® and PERLANE® are minimally cross-linked, making them similar to the natural hyaluronic acid found in the body.
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12/27/2006 -- FDA APPROVES RADIESSE® FACIAL FILLER FOR TWO NEW AESTHETIC INDICATIONS
Long-Lasting Filler from BioForm Medical Approved for Treatment of Facial Wrinkles and Folds; and for the Correction of HIV-Associated Facial Wasting
San Mateo, CA – December 27, 2006. BioForm Medical, Inc., a privately-held medical aesthetics company, today announced that the U.S. Food and Drug Administration (FDA) approved Radiesse®, the next-generation cosmetic dermal filler, for the long-lasting correction of moderate to severe facial wrinkles and folds such as nasolabial folds. Radiesse also received a second FDA approval for the long-lasting correction of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV). Radiesse is the first filler with advanced calcium-based microsphere technology that not only provides volume replacement to wrinkles, folds and sunken depressions but also stimulates the body to produce new collagen. This unique action restores the fullness and contours of a youthful, healthy appearance with sustained results that last an average of one year or more. Click here for more of this release
6/5/2006 -- ALLERGAN ANNOUNCES FDA APPROVAL OF JUVÉDERM™ GEL FAMILY OF PRODUCTS FOR THE TREATMENT OF FACIAL WRINKLES AND FOLDS
‘Next Generation’ Smooth Gel, Non-Animal Dermal Fillers Offer Natural, Long-Lasting Results -
(IRVINE, Calif., June 5, 2006) – Allergan, Inc. (NYSE: AGN), the makers of BOTOX® Cosmetic (Botulinum Toxin Type A), today announced the U.S. Food and Drug Administration (FDA)’s approval of the JUVÉDERM™ dermal filler gel family of products, a ‘next generation’ of hyaluronic acid dermal fillers that provide a smooth, long-lasting correction of facial wrinkles and folds. Proprietary, technologically advanced formulations of JUVÉDERM™ result in a smooth, natural look and contain the highest concentration of non-animal and cross-linked hyaluronic acid of any dermal filler currently available. These unique attributes provide optimal results with a single treatment in the majority of patients and deliver sustained results for up to six months or longer. Click here for more of this release
12/12/2003 -- Medicis Announces FDA Approval of Restylane, the First and Only Dermal Filler Made of Stable, Biodegradable Non-Animal Hyaluronic Acid
New Treatment Designed To Correct Facial Wrinkles And Folds For Longer Than 6 Months
SCOTTSDALE, Ariz.--(Business Wire)--Dec. 12, 2003-- Medicis (NYSE:MRX) today announced that the U.S. Food and Drug Administration (FDA) has approved Restylane®, an injection for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, the lines between the nose and mouth. Restylane is the first and only FDA-approved dermal filler made of a biodegradable non-animal stabilized hyaluronic acid (NASHA™). Hyaluronic acid is a natural substance found in all living organisms and provides volume and fullness to the skin…."The approval of Restylane is not only a very important milestone in the history of Medicis, but also represents a significant advance in cosmetic dermal fillers….With its proven track record for long-lasting efficacy and safety in more than one million procedures worldwide, we believe that Restylane will set a new standard for non-invasive cosmetic procedures." Click here for more of this release
4/15/2002 -- ALLERGAN’S BOTOX® COSMETIC RECEIVES APPROVAL BY THE FDA FOR THE TREATMENT OF GLABELLAR LINES (BROW FURROW)
New Cosmetic Indication Underscores Product’s Versatility
(Irvine, CA, April 15, 2002) – Allergan, Inc. (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has granted approval to BOTOX COSMETIC (botulinum toxin type A) for the temporary improvement in the appearance of moderate to severe glabellar lines in adult men and women 65 or younger. The approval specifically applies to the vertical lines between the eyebrows. In conjunction with this approval, BOTOX® will be marketed for this use under the name BOTOX® COSMETIC with dosing specific to treat frown lines. Click here for more of this release
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