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FDA Approves Cenestin For Menopause Symptoms CINCINNATI, OH -- March 25, 1999 -- The United States Food and Drug Administration has approved Duramed Pharmaceuticals, Inc.’s Cenestin(TM) (synthetic conjugated estrogens, A) Tablets, the new plant-derived synthetic conjugated estrogens product for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. Cenestin will be available by prescription within 90 days in two dosage strengths -- 0.625 mg and 0.9 mg. The average age of American women at menopause is 51. According to the American College of Obstetrics and Gynecologists, the first wave of Baby Boomer women (born 1945 to 1960) are now entering menopause and another 20 million will reach menopause in the next decade. Currently, more than 40 million women in the U.S. are over 50 and eligible to take either ERT (estrogen only) or HRT (estrogen with a progestin). "Women today are approaching menopause as a natural transition. They have a great deal of information and seek to make decisions that are affecting their body in partnership with their physician. They like to better understand why they are taking a prescription and the source of the medication," said Dr. Florence Comite, founder, Women's Health at Yale and associate clinical professor, Yale University School of Medicine. "Having a new plant- derived estrogen allows the physician the ability to tailor the specific medication to the individual woman's preference." Like all estrogen drug products, Cenestin should not be used in women with known or suspected pregnancy, breast cancer, or estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis, or thromboembolic disorders. Estrogens have been reported to increase the risk of endometrial carcinoma in postmenopausal women with an intact uterus. The most common adverse events reported in clinical experience with Cenestin included headache, insomnia, asthenia, nervousness, paresthesia and depression. E-mail this page to a friend or colleague! To print, use this version