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| |  FDA Decision Recognizes Complexity Of Premarin Conjugated Estrogens PHILADELPHIA -- May 6, 1997 -- Wyeth-Ayerst Laboratories, a division of American Home Products Corp., is gratified by the decision made today by the United States Food and Drug Administration (FDA) in ruling that all generic versions of Premarin(R) must be shown to contain the same active ingredient as Premarin. The decision recognizes that at this time there can be no synthetic substitute for Premarin, a product made from a naturally derived blend of hormones. "Based on currently available data, there is at this time no way to assure that synthetic generic forms of Premarin have the same active ingredients as the brand-name drug,” said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, in announcing the decision. “This is essential for determining they are equivalent to the brand drug, and is also a legal requirement for their approval." "This decision reinforces consumer confidence in the FDA as an agency responsible for protecting the public health,” stated Robert Essner, president, Wyeth-Ayerst Laboratories. "In this case, the FDA's decision acknowledges the public's right to trust that a generic provides the same safety, quality and efficacy they expect from the original medication." "Millions of women throughout the world take Premarin to help treat and prevent osteoporosis and postmenopausal symptoms, and studies have demonstrated the potential role of Premarin in treating other long-term conditions," Essner added. Premarin is the most prescribed drug in the United States. It is the estrogen studied in nearly 90 percent of hormone replacement studies conducted in the past five years and the subject of over 3,000 scientific investigations over the past 50 years. "Based on our understanding of how estrogens act within a women's body, it can not be concluded that a woman would react similarly to a generic product that has a different composition than Premarin," said Marc Deitch, MD, senior vice president, and medical director, Wyeth-Ayerst Laboratories. Wyeth-Ayerst Laboratories, a division of American Home Products Corp., is a research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular and metabolic disease therapies, central nervous system drugs, anti-inflammatory agents, vaccines and generic pharmaceuticals. Wyeth-Ayerst is the first U.S. company with a major research facility devoted exclusively to women's health. The Wyeth-Ayerst Women's Health Research Institute is actively engaged in research that addresses the health care needs women face during all phases of their lives. American Home Products Corp. is one of the world's largest research-based pharmaceutical and health care products companies and is a developer, manufacturer and marketer of prescription drugs and over-the-counter medications. It also develops vaccines, biotechnology, agricultural products, animal health care and medical devices.
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