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FDA Approves seven-day Estrogen Patch REDWOOD CITY, CA. -- September 23, 1999 -- Cygnus, Inc.’s seven-day 17B-Estradiol transdermal hormone replacement therapy patch was cleared for marketing by the United States Food and Drug Administration (FDA). Cygnus developed and has manufacturing rights for the seven-day transdermal patch, which the company refers to as E2III. Cygnus also has marketing rights to this product, and is in the process of assessing potential sales and distribution alternatives. "We’re very pleased that the E2III product was approved. The fact that this product and two previous Cygnus developed products that have been submitted to the FDA have been approved is a testament to the Company’s ability to formulate and produce products that are shown to be safe and effective," stated John C. Hodgman, Chairman, President and Chief Executive Officer of Cygnus. "This approval also represents the high quality of work and successful team efforts of the many people involved in this project, including the research and development, quality assurance, engineering and production groups." The NDA provides for the use of estradiol transdermal system 0.05, 0.075, and 0.1 mg per day for treatment of moderate to severe vasomotor symptoms associated with menopause and treatment of vulvar and vaginal atrophy. Estrogens should not be used by patients with known or suspected pregnancy, breast cancer, estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis or thromboembolic disorders. Estrogens have been reported to increase the risk of endometrial carcinoma. The Wyeth-Ayerst division of American Home Products provided most of the funding for the development of E2III and was responsible for the clinical trials as well as the submission of the NDA. In June 1999, Wyeth-Ayerst did not exercise its option to reacquire the rights to the two hormone replacement patches it had been funding with Cygnus. E-mail this page to a friend or colleague! To print, use this version