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Pacira Pharmaceuticals, Inc. Announces sNDA Submission for EXPAREL Nerve Block Indication
Expected PDUFA Date of
The timeline for review of the sNDA, under the Prescription Drug User
Fee Act (PDUFA), is 10 months. If the
EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting in the same fashion as current local anesthetics. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing analgesia with reduced opioid requirements for up to 72 hours. Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy procedures and additional studies are underway to further demonstrate the safety and efficacy in other procedures. Additional information is available at www.EXPAREL.com.
Pacira Pharmaceuticals, Inc.
Jessica Cho, 973-254-3574
Pure Communications, Inc.
Susan Heins, 864-286-9597