A.P. Pharma, Inc. (APPA) Resubmits New Drug Application for APF530, a Product Candidate for the Prevention of Chemotherapy-Induced Nausea and Vomiting
9/28/2012 10:34:17 AM
REDWOOD CITY, Calif.--(BUSINESS WIRE)--A.P. Pharma, Inc. (OTCBB: APPA), a specialty pharmaceutical company, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate, APF530, 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.
comments powered by