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Erbitux gets Swiss OK

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Merck KGaA receives the first approval for colorectal cancer therapy Erbitux (cetuximab), with clearance in Switzerland Dec. 1 for use in combination with irinotecan. The application was submitted to Swissmedic and the EMEA at the end of June; EU marketing authorization is expected in mid-2004. Erbitux is pending at FDA with a mid-February user fee goal. Bristol/ImClone resubmitted the Erbitux NDA August 14 based on new data from a Merck KGaA study (1Pharmaceutical Approvals Monthly June 1, 2003, In Brief)...
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