Pacira and FDA Resolve Lawsuit

Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA) reached resolution in a lawsuit filed by Pacira following a September 2014 Warning Letter issued by the FDA. The FDA confirmed 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. Pacira made certain changes to the EXPAREL label in order to clarify its indication. The labeling supplement also revised the description of the duration of EXPAREL’s effect. Read the letter from the FDA and Pacira’s statement.