Pacira Announces FDA Approval of Enhanced EXPAREL Manufacturing Process
PARSIPPANY, N.J., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the company’s enhanced manufacturing process for EXPAREL® (bupivacaine liposome injectable suspension) which is housed at a custom facility in Swindon, England under a partnership with Thermo Fisher Scientific Pharma Services. The company expects to start selling commercial product manufactured in this 200-liter suite later this year.
- This FDA approval underscores the quality assurance of our enhanced manufacturing process, which is essential as we scale the production of EXPAREL, said Dave Stack, chairman and chief executive officer of Pacira BioSciences.
- The patent, Manufacturing of Bupivacaine Multivesicular Liposomes, claims composition of EXPAREL prepared by the improved manufacturing process and has an expiration date of January 22, 2041.Pacira submitted this patent for listing in the FDAs Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) in July 2021.
- The companys long-acting local analgesic, EXPAREL (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012.
- EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting.