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In Brief: Idec Rituxan

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Executive Summary

Idec Rituxan: Company to supply FDA with manufacturing data regarding its anti-CD20 monoclonal antibody rituximab following receipt of Aug. 28 "not approvable" letter. Idec said, however, that FDA has found its clinical data package for non-Hodgkin's lymphoma to be sufficient to support licensure. FDA is requesting additional data regarding Rituxan's process validation and issues stemming from a May inspection of Idec's San Diego manufacturing facility. Company expects to submit the data within 60 days and anticipates approval by year end...

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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