On December 15, 2015, Pacira announced an amicable resolution with the United States in connection with its lawsuit filed on September 8, 2015, Pacira Pharmaceuticals, Inc. et al v. United States Food & Drug Administration et al, 15-cv-07055 (SDNY Sept. 8, 2015)(LAK). The resolution confirms that EXPAREL (bupivacaine liposome injectable suspension) is, and since 2011 has been, broadly indicated for administration into the surgical site to provide postsurgical analgesia.
The resolution resulted in an approved labeling supplement which clarified and revised the EXPAREL package insert, a settlement agreement articulating the legal terms of the resolution and a letter from Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research (CDER), formally rescinding the September 2014 Warning Letter. The pertinent documents are available below.
Summary of Key Points Regarding Breadth of EXPAREL Indication
Lawrence Goldkind, MD, Declaration Regarding Breadth of EXPAREL Indication
Summary of Key Points Regarding EXPAREL Treatment of Effect for up to 72 Hours After Surgery
Lee-Jen Wei, PhD, Declaration Regarding EXPAREL Treatment of Effect for Up To 72 Hours After Surgery
Alex Cahana, MD, DPhil, DAAPM, FIIP, Declaration