ARTICLE | Company News
Pacira's Exparel gets label expansion as nerve block
April 6, 2018 10:30 PM UTC
Pacira Pharmaceuticals Inc. (NASDAQ:PCRX) said late Friday that FDA approved an sNDA for Exparel bupivacaine as a nerve block administered via interscalene brachial plexus to produce regional analgesia in patients undergoing upper extremity surgeries.
In February, an FDA advisory committee voted 6-4 against approval of the sNDA, which Pacira had resubmitted following receipt of a complete response letter for the product in 2015. The CRL said that while Pacira submitted data from one study showing efficacy in the setting of femoral nerve block, a second efficacy study failed to demonstrate efficacy for intercostal nerve block...
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