Published in Medical Letter on the CDC and FDA, May 11th, 2003
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.
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