Exparel
Generic name: bupivacaine liposome
Treatment for: Postoperative Pain
FDA Accepts Exparel NDA
Pacira Pharmaceuticals Announces FDA Acceptance of Exparel New Drug Application for Pain Management
PARSIPPANY, N.J., Dec. 14, 2010 /PRNewswire/ -- Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, announced today that the New Drug Application (NDA) for Exparel, a long-acting bupivacaine for postsurgical pain management, has been accepted for filing by the U.S. Food and Drug Administration (FDA). Pacira submitted the Exparel NDA in September 2010 for the initial indication of postsurgical analgesia by local administration. The FDA also notified Pacira that its Prescription Drug User Fee Act (PDUFA) target date (the date the FDA expects to complete its review of the Exparel NDA) is July 28, 2011.
About Pacira
Pacira Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the development, commercialization and manufacture of novel pharmaceutical products, based on its proprietary DepoFoam drug delivery technology, for use in hospitals and ambulatory surgery centers. The company's most advanced product candidate, Exparel, a bupivacaine-based product, has completed Phase 3 clinical development for postoperative analgesia by infiltration. Exparel consists of bupivacaine encapsulated in DepoFoam, which is designed to address the limitations of widely used medications by enhancing their dosing and/or administration profile. Additional information about Pacira is available at www.pacira.com.
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James S. Scibetta, CFO, Pacira Pharmaceuticals, Inc. |
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973-254-3560 |
SOURCE Pacira Pharmaceuticals, Inc.
CONTACT: James S. Scibetta, CFO of Pacira Pharmaceuticals, Inc., +1-973-254-3560
Web Site: http://www.pacira.com
Posted: December 2010
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- Pacira Pharmaceuticals, Inc. Announces U.S. FDA Approval of Exparel For Postsurgical Pain Management - October 31, 2011
- Pacira Pharmaceuticals, Inc. Announces FDA Extension of Exparel PDUFA Target Date By Three Months - June 14, 2011
Exparel (bupivacaine liposome) FDA Approval History
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