Pacira Pharmaceuticals Inc. announced that it has reached an amicable resolution with the U.S. FDA in its lawsuit filed on Sept. 8, 2015. The resolution confirms that EXPAREL (bupivacaine liposome injectable suspension) is, and has been since 2011, broadly indicated for administration into the surgical site to provide postsurgical analgesia, according to the company.
“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 postsurgical opioid exposure by providing a non-opioid option like EXPAREL to as many patients as appropriate,” stated Dave Stack, CEO and chairman of Pacira. “This is especially important given the burgeoning U.S. opioid epidemic, underscored by the reality that one in 15 patients will go on to long-term use after receiving an opioid in the hospital setting.”
The U.S. Food and Drug Administration (FDA) confirms that EXPAREL has, since its approval on October 28, 2011, been approved for “administration into the surgical site to produce postsurgical analgesia” in a variety of surgeries not limited to those studied in its pivotal trials.
The September 2014 Warning Letter is formally withdrawn via a “Rescission Letter” from Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research (CDER) to Dave Stack. The United States acknowledges that the rescission of the Warning Letter and approval of the Labeling Supplement reflect the scope of the indication in the NDA that FDA approved on October 28, 2011.
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