Pacira Reports Favorable Resolution With FDA On EXPAREL

(RTTNews) - Pacira Pharmaceuticals, Inc. (PCRX) said it has achieved an amicable resolution with the United States in its lawsuit filed on September 8, 2015, which 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.

The FDA approved a labeling supplement which amends the EXPAREL Package Insert to clarify and reinforce that the use, efficacy and safety of EXPAREL is not limited to any specific surgery type or site.

In September 2014, the FDA Office of Prescription Drug Promotion issued Pacira a Warning Letter related to certain promotional materials.

Pacira took actions to address the immediate FDA concerns and minimize further disruption to its business. However, the company ultimately sought a court order to defend against any retroactive attempt to limit the broad indication for EXPAREL and restrict communications supported by the approved label.

The September 2014 Warning Letter is now formally withdrawn via a "Rescission Letter" from Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research to Dave Stack.