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FDA Revises Stand on Estrogen/Androgen Products In the Treatment of Hot Flashes

ROCKVILLE, MD - April 10, 2003 - In a proposal in today's Federal Register, the Food and Drug Administration (FDA) began a formal administrative process to examine the effectiveness of estrogen/androgen combination products for the treatment of hot flashes associated with the menopause.

FDA is acting because it does not believe there is substantial evidence that androgens contribute to the effectiveness of these combination products to treat hot flashes in menopausal women who do not find relief from these symptoms when using estrogens alone. Estrogen/androgen combination products were found effective for this indication under a determination FDA made in a 1976 Federal Register notice.

FDA is also offering affected parties the opportunity for a hearing on this issue.

FDA is aware of at least two currently marketed products affected by this proceeding. It has been FDA's long-standing policy to allow the continued marketing of drug products while matters such as these are being resolved, provided there is no documented serious public health or safety issue associated with such products.

The agency is also aware that these products are being prescribed for at least one indication, female sexual dysfunction that is not covered by the determination of effectiveness made in the 1976 Federal Register notice. The agency recognizes that the practice of medicine sometimes includes the widespread unapproved use of a drug product. In some cases, such a use may have potentially significant, if unproven, benefits.

There are also important benefits, however, in demonstrating the safety and effectiveness of new uses for marketed drug products. These benefits include making available to physicians and patients the best information about a drug's safe and effective use. Before such uses can be approved, the manufacturer must submit and FDA must review data from well-planned and executed clinical investigations substantiating the safety and effectiveness of a new use or regimen.

In this case, FDA has determined that the questions about the net benefits of estrogen/androgen combination products require resolution if the long-term availability of such products is to be supported for any use. Today's actions are designed to resolve whether substantial evidence of effectiveness exists for estrogen/androgen combination products for the treatment of hot flashes in menopausal women who do not find relief from these symptoms when using estrogens alone.

FDA encourages the development of clinically meaningful information about new uses of these combination products, including for the treatment of female sexual dysfunction. FDA is willing to work with sponsors interested in conducting clinical trials of drugs for that use (as well as others) and has provided some guidance on the design of clinical trials that could support an application for a drug for the treatment of female sexual dysfunction. This guidance document is available on the Internet at www.fda.gov/cder/guidance/3312dft.htm.

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