BioCentury
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FDA delays Sancuso PDUFA date again

June 3, 2008 1:31 AM UTC

ProStrakan (LSE:PSK) said FDA postponed the PDUFA date for an NDA for Sancuso because of resource constraints for a second time. A decision is now expected the week of July 7. In April, the agency pushed the action date for the transdermal granisetron patch to prevent chemotherapy-induced nausea and vomiting (CINV) back six weeks, to June 10 from May 2 (See BioCentury Extra, Wednesday, April 23, 2008). ...