Pacira Pharmaceuticals Inc. announced an amicable resolution with the FDA over a lawsuit filed on Sept. 8 on the use and labeling of bupivacaine liposome injectable suspension (Exparel).
The FDA had issued a warning letter to Pacira nearly a year ago regarding promotions of the drug. According to the warning letter, claims for new uses of Exparel and its efficacy for providing up to 72 hours of pain relief were misleading. The letter stated that the drug is only indicated for treatment