Resubmitted NDA Accepted for APF530 for Prevention of Chemotherapy-induced Nausea and Vomiting
A.P. Pharma announced that the FDA has accepted the resubmission of its New Drug Application (NDA) for APF530 for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV).
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of March 27, 2013. A.P. Pharma's NDA for APF530 was resubmitted to the FDA on September 27, 2012.
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.
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