Pacira Pharmaceuticals is suing the FDA to allow the company to promote its post-surgery pain drug for a wide range of surgeries, which FDA opposes, according to Reuters.
Exparel is approved by the FDA for site of surgery to produce post-surgery pain relief, specifically for bunionectomies and hemorrhoidectomies.
But, Pacira has marketed it for use in all types of surgeries, something the FDA sent a warning letter to the company about last year.
According to Reuters, the company claims, "that all of its marketing is on-label, and that the FDA is illegally trying to narrow the indication of the drug it has already approved after the fact," and "that even if it were trying to promote the drug off-label, it would have the right to do so as long as it did so truthfully."
