News and Trends: FDA Approvals: FDA Approvals and News - Omnilux New-U FDA Approved for Periorbital Wrinkles Photo Therapeutics, Inc., has received FDA approval on its over-the-counter light therapy device, Omnilux New-U, for the treatment of periorbital wrinkles. According to the company, Omnilux New-U has been clinically proven to reduce periorbital wrinkles and to treat the visible signs of aging, using a combination of alternate treatments of infrared and red light twice a week for 4 weeks. The clinical study conducted by Neil Sadick, M.D., of Weill Medical College of Cornell University Department of Dermatology, demonstrated a significant reduction in periorbital wrinkles and improvements in skin tone, clarity, smoothness and elasticity. FDA Issues Warning About STD Drugs on Internet The FDA issued Warning Letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the Internet to U.S. consumers for the prevention and treatment of sexually transmitted diseases (STDs). The products — marketed under the names Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus — claim to prevent or treat a variety of STDs, including herpes, chlamydia, human papilloma virus, cervical dysplasia, and HIV/AIDS. According to the FDA, these unapproved products pose a serious health threat to consumers who are unaware that they have not been proven safe or effective. Consumers who are currently using these products are advised to discontinue using them immediately and consult their healthcare professional if they have experienced any adverse effects that may be related to the use of these products. Photomodulation System 510-k Cleared for Over-the-Counter Sale The FDA granted 510(k) premarket approval notification to Light BioScience, LLC, to market its photomodulation system over the counter for treatment of periorbital wrinkles. The GentleWaves LED Photomodulation System is a light-based technology that received FDA clearance in 2004 for the treatment of periorbital wrinkles and rhytides by prescription. According to the manufacturer, this clearance designates the system as the first light-based device to enter the consumer marketplace for the treatment of periorbital wrinkles. Ipsen and Medicis Submit BLA for Reloxin in Aesthetics to the FDA Ipsen has submitted a Biologics License Application to the U.S. Food and Drug Administration’s Division of Dermatology and Dental Products for the botulinum toxin type A Reloxin for aesthetic indications (glabellar lines). This BLA submission by Ipsen is intended to address the concerns cited by the FDA when it declined to file the Reloxin BLA submitted by its U.S. distributor, Medicis, in late 2007. Medicis intends to commercialize Reloxin in the U.S. in accordance with the long-standing arrangement between Medicis and Ipsen. Changes from the original BLA submission relate primarily to sponsorship and ownership of the filing. IN BRIEF… MEDICIS ANNOUNCES… Dr. Ira D. Lawrence has been named Senior Vice President, Research and Development. In this position, Dr. Lawrence’s responsibilities include building a team focused on the successful design and execution of clinical trials, as well as designing and implementing a reliable and efficient clinical development and regulatory submission process.               Skin & Aging - ISSN: 1096-0120 - Volume 16 - Issue 4 - April 2008 - Pages: 10 - 10