Tamoxifen Information

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FDA/Center for Drug Evaluation and Research

On October 29, 1998, the Food and Drug Administration approved Nolvadex (tamoxifen citrate) for reducing the incidence of breast cancer in women at high risk for developing the disease. This new indication for tamoxifen, which has been used as a breast cancer treatment for more than 20 years, resulted from a recent study of the drug, conducted by the National Cancer Institute (NCI), in women who were judged to be at increased risk of breast cancer. The study showed that tamoxifen reduced the chance of getting breast cancer by 44 percent. The data also showed that tamoxifen treatment did not completely eliminate breast cancer risk, and that its longer term effects are not known.

In approving the drug for this new indication, FDA emphasizes that Nolvadex should be prescribed only for women at high risk for breast cancer following a medical evaluation of a woman's individual risk factors including age, personal health history and family history of breast cancer -- factors outlined in the approved labeling.

Tamoxifen is manufactured by Zeneca Pharmaceuticals, Wilmington, Del. The supplemental drug application for the new use of this product was reviewed and approved by FDA in six months. More information about Tamoxifen can be found below, including labeling. The clinical review will be posted as soon as it is available.

FDA Talk Paper (10/29/1998)
Tamoxifen Approval Letter (10/29/1998)
Final Approved Labeling Text (10/29/1998)
Patient Package Insert (10/29/1998)
Medical Review (11/10/98)
Oncology Advisory Committee Discussion on Tamoxifen (9/3/98)

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Date created: March 08, 2001; last update: July 7, 2005