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| |  FDA Approves Low-Dose Climara (Estradiol Transdermal System) For Treatment Of Menopausal Symptoms MONTVILLE, NJ -- April 10, 2001 -- The U.S. Food and Drug Administration (FDA) recently approved a new, expanded indication for Climara®. Climara 0.025mg/day has been recommended by the FDA as the starting dose for the treatment of menopausal symptoms and the prevention of osteoporosis, announced Berlex Laboratories, Inc., the U.S. affiliate of Schering AG, Germany. "I am very pleased to see this approval. There is growing scientific evidence that women can obtain substantial benefits of lower doses of estrogen, both on symptom relief and on long-term health maintenance," said Bruce Ettinger, M.D., Senior Investigator, Division of Research, Kaiser Permanente Medical Care Program and Clinical Professor of Medicine and Radiology, University of California, San Francisco. "Furthermore, studies are showing that using lower doses may be more tolerable for some women." "Low-dose Climara 0.025 mg/day is the only ERT available that provides the lowest effective dose of estrogen proven to treat menopausal symptoms and prevent osteoporosis," said Reinhard Franzen, VP, General Manager, Female Healthcare, Berlex Laboratories, Inc. "As a company dedicated to enhancing the quality of women's lives, we are proud to play an important role in the evolving science of low-dose estrogen therapy. Our Climara family of products helps ensure that women receive the appropriate dose of estrogen to meet their specific health care needs." Small, thin and transparent, Climara delivers a steady supply of 17-beta estradiol -- the same estrogen a woman's ovaries produce before menopause -- directly through the skin and into the bloodstream for seven full days. The estrogen in Climara is derived from natural plant sources (soy). Climara is available in four different dosage strengths, enabling physicians to customize the dosage to suit a woman's individual estrogen needs. Advanced 3M technology ensures that the patch is both comfortable and long lasting so that it stays on for an entire week. Climara 0.025 mg/day is also indicated for the relief of vulvar and vaginal atrophy associated with menopause and the prevention of osteoporosis. 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.
SOURCE: Berlex Laboratories, Inc.
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