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.