FDA Issues Warning Letter To Pacira Pharma Regarding EXPAREL

(RTTNews) - Pacira Pharmaceuticals, Inc. (PCRX) Thursday said it has received a warning letter from the U.S. Food and Drug Administration or FDA's Office of Prescription Drug Promotion, with reference to the company's certain promotional materials on its product EXPAREL.

Dave Stack, chief executive of Pacira said: "We take regulatory compliance very seriously and believe that our current labeling supports the claims being challenged by the FDA," "We plan to explain our position to the FDA and will provide an update upon resolution of these issues," he added.

EXPAREL is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia in adult patients 18 years of age or older.