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.