Pacira Pharma (PCRX) Announces FDA Acceptance of sNDA for EXPAREL Use in Pediatric Patients
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Pacira BioSciences Announces FDA Acceptance of sNDA for EXPAREL Use in Pediatric Patients
August 4, 2020 7:31 AM EDTsNDA submission based on positive Phase 3 data supporting expansion of the EXPAREL label to include use in children aged six and over
PARSIPPANY, N.J., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX) today announced the U.S. Food and Drug Administration (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... More
