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news.Pacira Pharmaceuticals, announced the US 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.
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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.
"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.
Pacira Pharmaceuticals is a specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients.
The company’s current emphasis is the development of non-opioid products for postsurgical pain control, and its lead product, EXPAREL (bupivacaine liposome injectable suspension), was commercially launched in the United States in April 2012.
EXPAREL and two other products have utilized the Pacira proprietary product delivery technology DepoFoam, a unique platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time.