NDA Resubmitted for APF530 for Prevention of Chemotherapy-Induced Nausea and Vomiting
A.P. Pharma announced that it has resubmitted its New Drug Application (NDA) to the FDA for its lead product candidate, APF530 (granisetron), for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV).
A.P. Pharma expects confirmation of acceptance from the FDA and a Prescription Drug User Fee Act (PDUFA) goal date within the next few weeks. The Company anticipates a six-month review by FDA.
APF530 contains the 5-HT3 antagonist, granisetron, formulated in the Company's proprietary Biochronomer drug delivery system, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection. Intravenous and oral formulations containing granisetron are approved for the prevention of acute-onset CINV, but not delayed-onset CINV.For more information call (650) 366-2626 or visit www.appharma.com.