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Celgene Revlimid user fee extension

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's action date for Celgene's myelodysplastic syndromes treatment Revlimid (lenalidomide) is Jan. 7 following a 90-day extension to allow further review of the firm's risk management program. Celgene's submission of "additional information" on its RevAssist RMP "has been considered by the FDA to be a major amendment to the Revlimid NDA," Celgene says Oct. 3. The extension comes on the heels of Celgene's Sept. 28 announcement that it has suspended a Phase III multiple myeloma trial after patients developed blood clots. The firm said the trial would resume within weeks after amending the protocol to include aspirin. A multiple myeloma NDA is slated for November...
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