Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, announced today that the New Drug Application (NDA) for EXPAREL™, a long-acting bupivacaine for postsurgical pain management, has been accepted for filing by the U.S. Food and Drug Administration (FDA).
Pacira submitted the EXPAREL NDA in September 2010 for the initial indication of postsurgical analgesia by local administration. The FDA also notified Pacira that its Prescription Drug User Fee Act (PDUFA) target date (the date the FDA expects to complete its review of the EXPAREL NDA) is July 28, 2011.