The FDA approved the use of anastrozole (Arimidex) for the adjuvant treatment of hormone-receptor positive early breast cancer in postmenopausal women.
In September 2002, the FDA approved a supplemental new drug application (sNDA) for Arimidex under the provisions for accelerated approval, with further follow-up required for full approval. The supplemental approval was based on recurrence-free survival data from the Arimidex Tamoxifen Alone or in Combination (ATAC) trial with a median duration treatment of 31 months.

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