FDA Approvals & NewsRadiesse Approved for Two New Aesthetic IndicationsRadiesse, a calcium hydroxylapatite-based filler agent was granted FDA approval for two indications:1. long-lasting correction of moderate to severe facial wrinkles and folds 2. long-lasting correction of lipoatrophy in people with human immunodeficiency virus.The CaHA microspheres in Radiesse are contained in a water-based gel, and this filler has been shown to be effective for 12 months in multiple clinical trials. In the nasolabial fold study, which was the pivotal study, 117 patients at four medical centers underwent treatment with Radiesse on one side of the face and a control agent (the human collagen product Cosmoplast) on the other. Six months after treatment, Radiesse was found to be more effective than the control for every outcome measured (p<0.0001).In the nasolabial fold study, the most important clinical findings included the following:• 82% of nasolabial folds treated with Radiesse showed improvement, as compared to those treated with the control agent (27% showed improvement).• After 6 months, the nasolabial folds that had been treated with Radiesse was rated more improved in 79% of patients, compared with only 5% of the nasolabial folds treated with the control agent. • The nasolabial folds that were treated with Radiesse required fewer amounts of this filler (1.2 cc) as compared to the folds treated with the control (2.35 cc).• Both products were safe and well tolerated. In all of the patients treated, Radiesse resulted in no granulomas and a comparable rate of nodules as the control. BioForm Medical, the manufacturer of Radiesse, also has FDA approval to treat vocal fold insufficiency with Radiesse.  MRI Contrast Agent May Have Link to Deadly DermopathyThe FDA issued a public health advisory to alert healthcare providers about a serious dermopathy that has affected 25 patients so far who have kidney failure and who have received a gadolinium-based contrast agent in high doses — amounts typical for patients to receive when undergoing magnetic resonance imaging (MRI) scans. Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD) is a disorder that occurs in patients who have a combination of kidney failure and acidosis. Only 200 reports of NSF/NFD have emerged worldwide since the disease was first identified in 1997. This disease’s origin is unknown, but it causes patients to experience tight rigid skin — so much so that it is difficult for these patients to bend their joints. In addition, NSF/NFD may result in fibrosis in body organs that may lead to organ failure and death.Of the 25 cases that prompted the public health advisory, 20 were in Denmark and five in Austria, and they occurred in patients during 2 weeks to 3 months after receiving a gadolinium-containing contrast agent. The FDA is presently investigating whether a true link exists, and you can learn more about this health advisory by logging onto the following site: www.fda.gov/cder/drug/advisory/gadolinium_agents_20061222.htm. New Class of Topical Antibiotic ApprovedThe FDA has issued an approvable letter for the topical antibiotic retapamulin ointment 1% (Altabax), which is indicated for the treatment of secondarily infected traumatic lesions, which are most commonly caused by Staphylococcus aureus and Streptococcus pyogenes.This antibiotic, which is manufactured by GlaxoSmithKline, is part of a new class of antibiotics known as pleuromutilins, which exhibit a low potential for developing resistance. An NDA for Altabax for the indication of treating impetigo is presently under review by FDA, and GlaxoSmithKline anticipates the outcome of this decision by the second quarter of this year.  New Hyaluronic Acid Filler ApprovedFDA has granted approval to Anika Therapeutics for its cosmetic tissue augmentation product, which is a chemically modified hyaluronic acid filler that also incorporates lidocaine. The filler is indicated for wrinkles, scars and lip augmentation. Five Companies Warned to Stop Compounding of Topical Anesthetic CreamsFDA has warned five firms to stop compounding topical aesthetic creams. The specific creams that prompted the warning are creams that are based on standardized versions of topical anesthetic creams marketed for general distribution. This move comes after two deaths occurred that were related to topical anesthetic creams compounded by two of the five compounding firms warned by the FDA. However, the three other compounding companies that were warned manufacture products that are similar to ones that were involved in the deaths. The firms that were cited include Triangle Compounding Company, University Pharmacy, Custom Scripts Pharmacy, Hal’s Compounding Pharmacy and New England Compounding Center.  In Brief…Iridex Signs Definitive Agreement…to acquire Laserscope Aesthetics Business, a leading global provider of medical laser systems for surgical and aesthetic applications. Under the terms of the agreement, Iridex Corp. will acquire certain assets and liabilities of Laserscope, including four patents, a license to an additional nine Laserscope patents, and a license under the Palomar hair removal patents for about $26 million in cash and $2 million in unregistered shares of Iridex common stock, subject to post closing adjustments. In addition, at the close of the transaction, Iridex will acquire between $7.3 million and $9.5 million in net assets.Galderma Laboratories Received…the number-one ranking in the eyes of dermatological healthcare professionals, according to the latest Verispan Pharmaceutical Company Image survey. Conducted every 2 years, the survey provides a comprehensive analysis and ranking of pharmaceutical companies and the industry’s image as perceived by key healthcare audiences. Galderma was number one in all 12 measured attributes, which included measures such as service orientation, research and development, orientation to patient information, value-added services, product portfolio, educational orientation and credibility.The Dermatology Nurses’ Association Announced…it will celebrate its 25th Anniversary Convention Feb. 1 to 4, in Washington, D.C. In addition to education sessions, participants will network and focus on the future of dermatology nursing as DNA celebrates its 25th Anniversary. During the meeting, members will reflect on the group’s history and the group will recognize members who have been with the association for 25 years and more. For more information, visit www.dnanurse.org.Joel Schlessinger, M.D., Was Installed…as the new President of the American Society of Cosmetic Dermatology and Aesthetic Surgery. A board-certified dermatologist, he is also a leader in cosmetic laser development, injectable fillers and dermatologic research. He is a founding member of this nonprofit professional association, which is dedicated to promoting the advancement of ethical cosmetic dermatology as a medical and surgical discipline.