Cardiome RSD1235 refusal to file
This article was originally published in Pharmaceutical Approvals Monthly
Cardiome/Astellas expect to resubmit the anti-arrhythmic RSD1235 in the third quarter following FDA's May 30 refusal to file the selective ion channel blocker. FDA's RTF letter cites "inconsistencies and omissions in the [electronically filed NDA] database" but does not request additional clinical data. Cardiome submitted RSD1235 March 31...
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