FDA accepts sNDA submission for Exparel postsurgical analgesia in children.- Pacira Biosciences

Pacira BioSciences, Inc. announced the FDA has accepted the submission of its supplemental new drug application (sNDA) seeking expansion of the Exparel (bupivacaine liposome injectable suspension) label to include single-dose infiltration to provide postsurgical analgesia in children aged six and over. The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is March 22, 2021. The sNDA is based on the positive data from the Phase III PLAY study of EXparel infiltration in pediatric patients undergoing spinal or cardiac surgeries. Overall findings were consistent with the pharmacokinetic and safety profiles for adult patients with no safety concerns identified at a dose of 4 mg/kg.