Review date set for injectable regional analgesia nerve block

Pacira Pharmaceuticals, Inc.announced that the FDA has notified the company that its supplemental New Drug Application (sNDA) for Exparel (bupivacaine liposome injectable suspension) as a nerve block for regional analgesia will be discussed at a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC).

The meeting is tentatively scheduled for 14-15 February, 2018. A definitive date for the advisory committee meeting is expected to be published by FDA in the Federal Register at least 15 days prior to such meeting. The Prescription Drug User Fee Act (PDUFA) goal date for completion of review by FDA of 6 April 2018 remains unchanged.