FDA accepts Pacira application for expanded use of post-op pain med

The FDA has accepted for review Pacira BioSciences’ (PCRX +0.1%) supplemental marketing application seeking expansion of EXPAREL (bupivacaine liposome injectable suspension) label to include single-dose infiltration to provide postsurgical analgesia in children aged six and over.

The agency’s action date is March 22, 2021.

Last year, in December, the company announced positive results from late-stage Play study in pediatric patients undergoing spinal or cardiac surgeries.

https://seekingalpha.com/news/3599880-fda-accepts-paciras-supplement-application-for-expanded-use-of-exparel-for-postoperative-pain