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| |  FDA Approves Two New Doses of Climara Transdermal Estrogen Therapy MONTVILLE, NJ -- July 29, 2003 -- Berlex Laboratories, Inc., announced today that two new strengths of Climara® (estradiol transdermal system) for the relief of symptoms that women often experience following a hysterectomy or during menopause are now available in pharmacies. The new doses, recently approved by the U.S. Food and Drug Administration (FDA), will continuously deliver 0.0375 mg or 0.06 mg of estradiol per day in convenient, once-a-week patches. All strengths of Climara (0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg of estradiol per day) are applied only once a week, and are indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause (such as hot flashes and night sweats), vulvar and vaginal atrophy symptoms (such as vaginal dryness), and the prevention of postmenopausal osteoporosis. With the addition of two new doses, the Climara product line now offers the broadest dosing range available of any transdermal hormone therapy product. All six Climara doses come in thin, transparent patches that are easily affixed to the skin and deliver a plant-based estrogen transdermally using the benefits of 3M technology. "Interim doses will help healthcare providers more effectively customize therapy to suit each woman's individual estrogen needs," said Marie Foegh, M.D., Sc., Vice President, Clinical Development, Female Healthcare at Berlex Laboratories, Inc. "Women can now have their dose adjusted to find the lowest effective dose that provides symptom relief while preventing bone loss." With transdermal delivery, Climara has a favorable side effect profile, with low rates of nausea and gastrointestinal complaints that may be associated with oral hormonal treatments. Estrogens should not be used by patients with known or suspected pregnancy, breast cancer, estrogen-dependant neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis, or thromboembolic disorders. Estrogens have been reported to increase the risk of endometrial carcinoma. For women with questions about menopause or osteoporosis, the North American Menopause Society has created a comprehensive guidebook designed to help women better understand the physical and emotional changes that occur during this time. Supported by an unrestricted educational grant from Berlex Laboratories, makers of Climara, the Menopause Guideboook is available on http://www.menopause.org. Berlex did not influence any of its contents. For more information about Climara, visit http://www.clearlyclimara.com.
SOURCE: Berlex Laboratories, Inc.
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