ARTICLE | Data Byte
At least 8 PDUFA dates on deck in September
Three submissions are under FDA priority review
September 3, 2022 12:31 AM UTC
At least eight PDUFA action dates are on deck from FDA in September.
There are three resubmissions in the batch, all of which received complete response letters citing manufacturing issues: Rolontis eflapegrastim from Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI), Pedmark sodium thiosulfate Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX:FRX) and daxibotulinumtoxinA from Revance Therapeutics Inc. (NASDAQ:RVNC). ...