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SuperGen Dacogen rolling NDA

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

SuperGen plans to complete submission of Dacogen (decitabine) for myelodysplastic syndrome (MDS) "within the third quarter." The rolling submission began with the chemistry, manufacturing & controls section, the firm announced June 1. FDA cleared Pharmion's MDS agent Vidaza (azacitidine) May 19, more than a month ahead of the product's June 29 priority review deadline. SuperGen assured investors in February that Vidaza approval will not block Dacogen from being approved (1Pharmaceutical Approvals Monthly March 1, 2004, p. 5)...

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