Pacira Pharmaceuticals, Inc. Announces Submission Of Prior Approval Supplement For Additional EXPAREL® Manufacturing Suite
12/6/2013 9:10:40 AM
PARSIPPANY, N.J.--(BUSINESS WIRE)--Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced that it has submitted a Prior Approval Supplement (PAS) with the U.S. Food and Drug Administration (FDA) for an additional bulk manufacturing suite for EXPAREL® (bupivacaine liposome injectable suspension). Under the reauthorization of the Prescription Drug User Fee Act (PDUFA), the FDA established a 4-month PDUFA goal for approval of a manufacturing PAS. Should the FDA accept the PAS for review, a PDUFA date in early April 2014 is anticipated.
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