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IDEC Rituxin

Executive Summary

Rituximab receives "complete review" letter Sept. 19 for expanded non-Hodgkin's lymphoma indication including eight weekly doses per treatment, multiple courses of treatment and treatment of patients with bulky disease. FDA requested inclusion of two safety and efficacy tables in the product package insert. IDEC submitted the supplemental BLA Oct. 29, 1999; Rituxin was approved in 1997 for the treatment of patients with relapsed or refractory, low grade or follicular, CD20 positive, B-cell non-Hodgkin's lymphoma

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