A.P. Pharma resubmits APF530 NDA

A.P. Pharma Inc. (OTCBB:APPA) resubmitted an NDA to FDA for APF530 to prevent chemotherapy-induced nausea and vomiting (CINV). The company said the application includes responses to FDA's 2010 complete response letter that requested bioavailability, metabolism and QT studies in volunteers. APF530 is a long-acting formulation of granisetron, a serotonin (5-HT3) receptor antagonist that uses the company's Biochronomer drug delivery system (see BioCentury Extra, March 19, 2010). ...