FDA Advisory Committee meeting to consider Exparel for regional analgesia is to be held on 14-15 February 2018.- Pacira Pharma.
Pacira Pharmaceuticals, Inc. announced that the FDA has posted briefing materials for the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) meeting that will review the company�s supplemental New Drug Application seeking expansion of the current Exparel (bupivacaine liposome injectable suspension) label for infiltration to include use as a nerve block for regional analgesia.
The Advisory Committee meeting is scheduled for February 14-15, 2018. The sNDA filing is based on positive data from a Phase III study of Exparel in femoral nerve block for total knee arthroplasty (lower extremity) and a Phase III study of Exparel in brachial plexus block for shoulder surgeries (upper extremity). It includes data from eight company-sponsored studies with safety and pharmacokinetic data through 120 hours. In addition, the sNDA includes data from two investigator-initiated studies that provide additional experience in smaller, peripheral nerve block settings.
The Prescription Drug User Fee Act (PDUFA) date for completion of the FDA�s review of the company�s sNDA for ExparelL is April 6, 2018.
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