Pacira Pharma Reports Changes to EXPAREL Label, Indication Not Affected

Pacira Pharmaceuticals, Inc. PCRX today announced the U.S. Food and Drug Administration's (FDA) approval of changes to the EXPAREL packaging and label proposed by the Company as part of a routine label supplement application, submitted on November 27, 2013. The approved label changes are limited to revisions pertaining to the product's storage, instructions of use and use in special populations, and do not impact its indication. To review specific changes, please refer to the updated Prescribing Information at http://www.exparel.com/pdf/EXPAREL_Prescribing_Information.pdf. “We're pleased to announce routine, but important updates to our label and look forward to continuing discussions with the FDA as we approach the March 2015 PDUFA date for our supplemental new drug application for a nerve block indication,” said Dave Stack, CEO of Pacira. EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia. Pacira has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a nerve block indication for EXPAREL, with a target Prescription Drug User Fee Act (PDUFA) date of March 5, 2015.