This article was originally published in Pharmaceutical Approvals Monthly
Anastrozole is approved Sept. 1 for first-line treatment of locally advanced or metastatic breast cancer in postmenopausal women with hormone receptor positive or hormone receptor unknown disease. The company will submit annual safety and survival updates on its pivotal studies to FDA until 75% of study patients are deceased. The aromatase inhibitor was originally approved in 1996 for use following failure on AstraZeneca's Nolvadex (tamoxifen
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