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Idec Zevalin EU delay

Executive Summary

European launch of Idec's Zevalin (ibritumomab) is delayed until the second half of 2003 due to "technical compliance issues" at fill/finish manufacturer DSM Catalytica's Greenville, N.C. facility. Launch will follow EU-mandated facility upgrade at Greenville; facility "modification" will not affect U.S. distribution of the non-Hodgkin's lymphoma therapy, Idec said. Schering AG, which distributes Zevalin outside the U.S., had expected a second half 2002 EU launch. U.S. approval of Zevalin was also delayed by GMP problems at Catalytica; FDA approved Zevalin Feb. 19 (1"The Pink Sheet" Feb. 25, p. 18)...
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