Pacira Pharmaceuticals Inc. Feb. 11 announced it has resolved matters in a recent warning letter from the Food and Drug Administration on promotional materials for Exparel (bupivacaine liposome injectable suspension).
Exparel is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia in adults.
The company, which announced receiving the warning letter on Sept. 25, 2014 12 PLIR 1358, 9/26/14, said it has been in “constructive” discussions with the FDA’s Office of Prescription Drug Promotion (OPDP) since it received the letter.
In the warning letter, the FDA said educational flashcards and a journal ad for Exparel provided ...
Learn more about Bloomberg Law or Log In to keep reading:
See Breaking News in Context
Bloomberg Law provides trusted coverage of current events enhanced with legal analysis.
Already a subscriber?
Log in to keep reading or access research tools and resources.