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Update on FDA Registration of Actemra, a Humanized Anti-Human IL-6 Receptor Monoclonal Antibody for Rheumatoid Arthritis
Chugai Pharmaceutical Co., 08/03/09
Chugai Pharmaceutical Co., Ltd. and F. Hoffmann–La Roche Ltd. announced that FDA has accepted the complete response resubmission that Roche made to the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for Actemra the humanized anti–human IL–6 (interleukin–6) receptor monoclonal antibody, following the receipt of the Complete Response Letter in September 2008.
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