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# FDA Expanded Approval for Pacira Pain Drug
- URL: https://www.fdaweb.com/fda-expanded-approval-for-pacira-pain-drug/
- Published: 2018-04-09T12:00:00.000Z
- Updated: 2026-09-14T23:58:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141178

FDA has approved a Pacira Pharmaceuticals NDA for Exparel (bupivacaine liposome injectable suspension) for expanded use as an interscalene brachial plexus nerve block to produce post-surgical regional analgesia following shoulder surgery in adults. Previously, Exparel was approved for local administration to provide post-surgical analgesia. Interscalene brachial plexus nerve block works by anesthetizing the body’s nerves nearest the shoulder in order to help curb pain, an FDA release explains.  

Exparel’s new indication is being approved based on the results of one multicenter clinical study, which demonstrated that the product is safe and effective for the intended use, the agency says. “In accordance with recommendations made by an FDA advisory committee in February, the agency has determined that clinical trial data is not sufficient to support the general use of Exparel for regional nerve blocks for post-surgical analgesia other than shoulder surgery,” it says. “As such, the product’s updated labeling approved today clearly articulates both Exparel’s limitations of use as well as the most up-to-date safety and efficacy data associated with its new interscalene brachial plexus nerve block for post-surgical analgesia indication.”