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BRISTOL-MYERS SQUIBB TAXOL REFRACTORY BREAST CANCER APPROVAL

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Executive Summary

BRISTOL-MYERS SQUIBB TAXOL REFRACTORY BREAST CANCER APPROVAL April 12 comes nine months after the company's July 1, 1993 filing of the supplemental NDA (20-262/S-004) seeking permission to include an indication for metastatic breast cancer in labeling for Taxol (paclitaxel). The approval also comes just four months after FDA's Oncologic Drugs Advisory Committee recommended the drug for the breast cancer treatment indication Dec. 15. Taxol was originally approved Dec. 29, 1992 for treatment of metastatic ovarian cancer.

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