Dacogen deadline is May 15
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
MGI/SuperGen's Dacogen (decitabine) has a new PDUFA date of May 15 following FDA's acceptance of the firm's Nov. 15 response to a September "approvable" letter (1Pharmaceutical Approvals Monthly December 2005, In Brief). The firm's submission includes FDA-requested analyses regarding transfusion data for the myelodysplastic syndromes therapy...