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FDA Grants Priority Review Status to Early Breast Cancer Indication for Arimidex (Anastrazole) WILMINGTON, DE -- April 15, 2002 -- The U.S. Food and Drug Administration (FDA) has granted a six-month Priority Review Status to the AstraZeneca’s supplemental new drug application (sNDA), which provides data for the use of Arimidex® (anastrozole) Tablets in the adjuvant treatment of early breast cancer in postmenopausal women. AstraZeneca filed the sNDA with the FDA for Arimidex on March 4, 2002, having received Fast-Track Designation in December of 2001, allowing a rolling submission. Priority Review Status is granted for new drugs or indications that represent a significant improvement in efficacy or safety over existing treatments. Priority Review Status for Arimidex was based on data from the ATAC (Arimidex and Tamoxifen, Alone or in Combination) study -- the largest breast cancer treatment trial ever conducted, including over 9,300 postmenopausal women with early breast cancer. Arimidex is currently FDA-approved for first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and also for treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Arimidex can cause fetal harm when administered to a pregnant woman. Before starting treatment, pregnancy must be excluded (see warnings in full prescribing information). Common side effects seen in clinical trials included hot flashes, nausea, asthenia, pain, back and bone pain and increased cough. Joint pain and stiffness has also been reported. SOURCE: AstraZeneca E-mail this page to a friend or colleague! To print, use this version