Pacira Pharmaceuticals, Inc. Announces Receipt of FDA Warning Letter
PARSIPPANY, N.J.--(BUSINESS WIRE)--Sep. 25, 2014-- Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced the receipt of a Warning Letter (attached for reference) from the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) referencing certain promotional materials on EXPAREL® (bupivacaine liposome injectable suspension).
“We take regulatory compliance very seriously and believe that our current labeling supports the claims being challenged by the FDA,” said Dave Stack, president, chief executive officer and chairman of Pacira. “We plan to explain our position to the FDA and will provide an update upon resolution of these issues.”
EXPAREL is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia in adult patients 18 years of age or older.
