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Zeneca Zoladex

Executive Summary

Goserelin acetate 3.6 mg depot and 10.8 mg depot approved July 27 for use in combination with flutamide (Schering-Plough's Eulexin) for the management of locally confined stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Zeneca filed supplemental NDAs 19-726/S-024 and 20-578/S-003 on Aug. 11, 1997 for the new indication for the depot formulations. Zoladex was previously approved as monotherapy for advanced prostate cancer
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PS032611

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