FDA declines to expand approval of Pacira's Exparel for postsurgical analgesia
The US Food and Drug Administration has declined to expand the approval of Exparel (bupivacaine), manufactured by Pacira Pharmaceuticals, to include sue in nerve block to provide postsurgical analgesia.
The company submitted the new filing for Exparel, which is a combination of the local anesthetic bupivacaine with the company’s DepoFoam drug-delivery system, for approval in May 2014, supported by data from a Phase III trial showing the treatment was associated with significantly better pain scores versus placebo in patients who underwent total knee arthroplasty.
Pacira will immediately schedule an End-of-Review meeting with the Division of Anesthesia, Analgesia and Addiction Products of the Center for Drug Evaluation and Research to discuss the contents of the Complete Response Letter.
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