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Trials & Filings

Pacira Files PAS for Exparel

Plans to add bulk manufacturing suite for postsurgical analgesic

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Pacira Pharmaceuticals has submitted a Prior Approval Supplement (PAS) with the FDA for an additional bulk manufacturing suite for Exparel (bupivacaine liposome injectable suspension). Under the reauthorization of the Prescription Drug User Fee Act (PDUFA), the FDA established a four-month PDUFA goal for approval of a manufacturing PAS. Should the FDA accept the PAS for review, a PDUFA date in early April 2014 is anticipated.

Exparel is manufactured at the Pacira FDA-approved Science Center Campus facility located in San Diego. It is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. Exparel represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting in the same fashion as current local anesthetics.

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