Posted by Michael Wonder on 04 Aug 2020
Pacira BioSciences announces FDA acceptance of sNDA for Exparel use in paediatric patients
4 August 2020 - sNDA submission based on positive Phase 3 data supporting expansion of the Exparel label to include use in children aged six and over.
Pacira BioSciences today announced the U.S. FDA has accepted the submission of its supplemental new drug application seeking expansion of the Exparel (bupivacaine liposome injectable suspension) label to include single-dose infiltration to provide post surgical analgesia in children aged six and over.
The expected action date by the FDA under the Prescription Drug User Fee Act is 22 March 2021.
