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In Brief: Zeneca's Zoladex

Executive Summary

Zeneca's Zoladex: Breast cancer indication was submitted to FDA on Aug. 31, 1994. A typo in the Jan. 1 issue of "The Pink Sheet" incorrectly placed the filing at the beginning of that month. Zeneca filed a separate NDA (20-515) for the indication with FDA's Division of Oncology Drug Products, where it received a "6S" review (standard review of a new claim for an already marketed drug). The original NDA 19-726 for prostate cancer and endometriosis was filed with the Metabolism & Endocrine Division. A supplement (S-017) was added to the original NDA to provide for the new breast cancer labeling...



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