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.
"The resubmission of the APF530 NDA is a pivotal milestone for A.P.
Pharma and brings this important therapeutic option one step closer to
cancer patients suffering from CINV," said John B. Whelan, A.P. Pharma's
president and chief executive officer. "Now that we have resubmitted the
NDA, our focus will shift to pre-marketing and pre-commercialization
activities in anticipation of potential FDA approval of APF530."