The Committee met to discuss a supplemental new drug application (sNDA) for Exparel (bupivacaine liposomal injectable suspension), submitted by Pacira Pharmaceuticals, Inc. (Pacira). A majority of the Committee, 6 of 10 members, voted that the data submitted by Parica for Exparel do not support approval of an additional indication for nerve block.
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Earlier Event: February 14Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee
Later Event: March 1Vaccines and Related Biological Products Advisory Committee