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Thalomid myeloma sNDA “approvable”

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Celgene's immunomodulatory drug Thalomid (thalidomide) has received a second "approvable" letter for treatment of multiple myeloma, the firm announces Nov. 15. FDA appears to be suggesting limiting the indication to newly diagnosed patients: "FDA has requested revised product labeling with the specific indication of newly diagnosed multiple myeloma and updated safety information, as well as some additional patient information to finalize its review," Celgene reports. The myeloma sNDA was originally submitted in December 2003; an initial approvable letter was issued in October 2004 (Pharmaceutical Approvals Monthly April 2005, In Brief). Thalomid is currently approved for treatment of erythema nodosum leprosum...

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