AP Pharma Reports FDA Acceptance Of APF530

FDA has accepted to review AP Pharma’s New Drug Application (NDA) for APF530, for the potential treatment of chemotherapy-induced nausea and vomiting (CINV).

APF530 is a long-acting formulation of granisetron that utilizes the company’s proprietary biochronomer drug delivery system. Based on the Prescription Drug User Fee Act (PDUFA), the FDA has issued an action date of March 18, 2010.

Ronald Prentki, president and CEO of AP Pharma, said: “The acceptance of the APF530 NDA represents another important step towards providing physicians and patients with a potential new long-acting therapeutic agent to combat chemotherapy-induced nausea and vomiting.

“Our team recognizes the important role APF530 could play in cancer care, and we are dedicated to working with the FDA as it reviews our NDA submission, he added.