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Idec/Genentech Rituxan Label May Add Detailed Bulky NHL Data By Year’s End

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Idec and Genentech have responded to a Sept. 19 "complete review" letter from FDA for the firms’ Rituxan sBLA to add expanded clinical data to labeling for the non-Hodgkin’s lymphoma (NHL) agent. The companies anticipate approval of the supplement by year’s end.
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