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Pacira announces resolution of lawsuit regarding EXPAREL indications

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Pacira Pharmaceuticals recently announced it has reached a resolution with the United States regarding a lawsuit over indications for EXPAREL (bupivacaine liposome injectable suspension), the company’s non-opioid postoperative analgesic.

“We are pleased to announce a successful collaboration with the FDA to resolve this matter in an expeditious and meaningful way that allows us to get back to the important task at hand — reducing post-surgical opioid exposure by providing a non-opioid option like EXPAREL to as many patients as appropriate,” Dave Stack, chief executive officer and chairman of Pacira, said in a press release.

The resolution to the lawsuit, which was initially filed Sept. 8, 2015, confirms EXPAREL’s indication for postoperative surgical site injection. Confirmation of the approval from the FDA extends forward from Oct. 28, 2011. Other developments related to the resolution include withdrawal of the September 2014 Warning Letter issued by the FDA, as well as approval of labeling supplement that clarifies limitations on surgeries EXPAREL is indicated for, proper dosage and administration of the drug and reinforcement of the results of treatment with EXPAREL.

Reference:

www.pacira.com