A.P. Pharma, Inc. Announces PDUFA Action Date for APF530 New Drug Application Resubmission
Published: Oct 16, 2012
REDWOOD CITY, Calif.--(BUSINESS WIRE)--A.P. Pharma, Inc. (OTCBB: APPA), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s resubmission of its New Drug Application (NDA) for APF530. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of March 27, 2013. APF530 is a long-acting formulation of granisetron and is being developed for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV).