Navigation Links
Pacira Pharmaceuticals, Inc. Announces FDA Extension of EXPAREL™ PDUFA Target Date by Three Months
Date:6/14/2011

PARSIPPANY, N.J., June 14, 2011 /PRNewswire/ -- Pacira Pharmaceuticals, Inc., (Nasdaq: PCRX), an emerging specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for EXPAREL™ (Bupivacaine Extended-Release Liposome Injection) by three months. The new PDUFA goal date is October 28, 2011.

The FDA requested additional information from Pacira, which the company has submitted. The FDA determined that this information constituted a major amendment. The agency has the option to extend the PDUFA goal date when a sponsor submits a major amendment to an NDA within three months of the PDUFA goal date to provide the FDA time to complete the review.

About Pacira

Pacira Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the development, manufacture and commercialization of novel pharmaceutical products, based on its proprietary DepoFoam drug delivery technology, for use in hospitals and ambulatory surgery centers. In December 2010, Pacira announced that its New Drug Application (NDA) for EXPAREL, the company's most advanced investigational product candidate, had been accepted for filing by the U.S. Food and Drug Administration (FDA). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 28, 2011 for the review of the EXPAREL NDA. EXPAREL is a bupivacaine-based product and has completed extensive 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<
'/>"/>

SOURCE Pacira Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Pacira Pharmaceuticals, Inc. Appoints Two Life Sciences Industry Veterans to Its Board of Directors
2. Pacira Pharmaceuticals, Inc. to Present at UBS Global Specialty Pharmaceuticals Conference
3. Pacira Pharmaceuticals, Inc. Announces EXPAREL™ Data Presentations at the International Anesthesia Research Society 2011 Annual Meeting
4. Pacira Pharmaceuticals, Inc. Announces Phase 3 EXPAREL™ Data Presentation at the American Society of Colon and Rectal Surgeons 2011 Annual Meeting
5. Pacira Pharmaceuticals, Inc. Reports First Quarter 2011 Financial Results
6. Pacira Pharmaceuticals, Inc. Announces EXPAREL™ Data Presentations
7. Pacira Pharmaceuticals, Inc. Announces Timing for First Quarter 2011 Financial Results Webcast and Conference Call
8. Pacira Pharmaceuticals to Present at BioCentury Future Leaders in the Biotech Industry Conference
9. Pacira Pharmaceuticals Reports Fourth Quarter and 2010 Financial Results
10. Pacira Pharmaceuticals to Present at the Barclays Capital 2011 Global Healthcare Conference
11. Pacira Pharmaceuticals EXPAREL™ Data to be Featured at 2011 ASCPT 112th Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... Jan. 23, 2015 /PRNewswire/-- Harwood Feffer LLP ( www.hfesq.com ) ... of Advaxis, Inc. ("Advaxis" or the "Company") (NASDAQ: ... its fiduciary duties to shareholders. On January ... website reporting that Advaxis had misrepresented the clinical data ...
(Date:1/23/2015)... 23, 2015  iMD Companies, Inc. (ICBU) has repositioned itself as ... and grab a foothold in the hydroponic, hemp and medical ... a presence in the sector, and recently partnering with the ... hemp and medical marijuana, iMD is committing to bring its ...
(Date:1/23/2015)... 2015  CytoSorbents Corporation (NASDAQ CM: CTSO), a critical ... adsorber to reduce deadly inflammation in critically-ill and ... net of transaction costs, in non-dilutive funding as ... Certificate Transfer Program sponsored by the New Jersey ...
Breaking Medicine Technology:Harwood Feffer LLP Announces Investigation of Advaxis, Inc. 2iMD Companies Poised to Make Impact in Multi-Billion Dollar Medical Marijuana Sector With Recent Investments and Strategic Partnerships 2CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 2CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 3
... Roper Industries, Inc.   (NYSE: ... 2009, ended December 31, 2009 , will be released before the ... to discuss these results has been scheduled for 8:30 AM ET ... accessed via webcast or by dialing +1 888-539-3679 (US/ Canada ) or ...
... SAN DIEGO , Jan. 20 First Coast ... to treat breast cancer with the addition of a Naviscan PEM ... in the nation to use both a PEM scanner and the ... , AccuBoost is a technique for whole breast irradiation that is ...
Cached Medicine Technology:First Coast Oncology Deploying Both Naviscan(TM) PEM and AccuBoost(TM) Assisted Therapy to Optimize Breast Cancer Treatment 2First Coast Oncology Deploying Both Naviscan(TM) PEM and AccuBoost(TM) Assisted Therapy to Optimize Breast Cancer Treatment 3
(Date:1/22/2015)... The U.S. Pharmacopeial Convention is pleased to announce ... Services at North Carolina State’s College of Veterinary Medicine ... Award for Distinguished Volunteer Service—the organization’s highest award. ... of volunteer experts to direct its work to improve ...
(Date:1/22/2015)... Woodloch Pines, an all-inclusive family resort ... as the number one best large hotel for families in ... for their annual Travelers’ Choice Awards. , TripAdvisor represents ... is home to millions of unbiased and honest traveler reviews. ...
(Date:1/22/2015)... The Incredible Bulk is a revolutionary method put together ... by up to 30lbs in less than 12 weeks without ... Stevenson, prompting an investigative review. , “Our Incredible Bulk ... formula that allows the body to pack on a massive ...
(Date:1/22/2015)... 22, 2015 The federal court overseeing thousands ... District Court, Southern District of West Virginia has upheld a ... proceeding’s first bellwether trial. In an Order dated January 21st, ... after finding that C.R. Bard had not proven a miscarriage ...
(Date:1/22/2015)... released a new blog post explaining the main features of ... Auto insurance quotes help many drivers find the best coverage ... an agent or visit an agency for price information. These ... http://autocarinsurancebest.com/ . , Every business who relies heavily on transportation ...
Breaking Medicine News(10 mins):Health News:Gigi Davidson, Pioneer in Veterinary Pharmacy and Leader in Pharmacy Compounding, honored with USP’s Beal Award for Dedication to Public Health 2Health News:Gigi Davidson, Pioneer in Veterinary Pharmacy and Leader in Pharmacy Compounding, honored with USP’s Beal Award for Dedication to Public Health 3Health News:Gigi Davidson, Pioneer in Veterinary Pharmacy and Leader in Pharmacy Compounding, honored with USP’s Beal Award for Dedication to Public Health 4Health News:TripAdvisor Names Woodloch Pines Best Hotel for Families in America 2Health News:TripAdvisor Names Woodloch Pines Best Hotel for Families in America 3Health News:The Incredible Bulk: Review Examining Ben Pakulski’s Brand New Bulking Muscle Building Diet Program Released 2Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 2Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 3Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 4Health News:Commercial Auto Insurance Provides Several Important Features! 2
... , WASHINGTON, Oct. 16 The following is attributed to ... "USDA has confirmed that hogs at the Minnesota State Fair ... USDA,s National Veterinary Services Laboratories expects to have confirmatory results ... given that much like humans, hogs can contract influenza viruses. ...
... reconstruction may make speaking, eating easier, study finds , ... cancer patients can spell trouble for the palate, but ... preserve the ability to speak clearly and eat most ... to reconstruct the area after tonsil tumors are removed. ...
... stem cells given early in pregnancy might save infants ... (HealthDay News) -- U.S. researchers are testing a new ... in babies while they,re still in the womb. , ... therapeutic stem cells that have been treated to speed ...
... ... University Edwardsville School of Pharmacy achieved a 97.26 percent passing rate on the North ... percentage points above the average nationally for all those taking the exam. , ... Edwardsville, IL (Vocus) October ...
... Texas, Oct. 16 On Friday, October 16, U.S. President ... than 2,000 service leaders in Texas to celebrate the 20th ... call to Americans to serve in their communities. , The ... he invoked "A Thousand Points of Light" to salute and ...
... Mich., Oct. 16 Here,s a health idea that Democrats ... factors that cause diabetes, both parties equally supported public health ... by the University of Michigan showed Republicans were less supportive ... diabetes got their illness because of social or economic factors ...
Cached Medicine News:Health News:Strides Made in Tonsil Cancer Repair 2Health News:Transplant May Treat Metabolic Disorders in Womb 2Health News:Pharmacy Class of 2009 Achieves 97.26 Percent NAPLEX Pass Rate 2Health News:Pharmacy Class of 2009 Achieves 97.26 Percent NAPLEX Pass Rate 3Health News:President Barack Obama Joins President George H.W. Bush to Celebrate the 20th Anniversary of the 'Points of Light' Volunteer Movement and Extend the Call of Service to the Nation 2Health News:President Barack Obama Joins President George H.W. Bush to Celebrate the 20th Anniversary of the 'Points of Light' Volunteer Movement and Extend the Call of Service to the Nation 3Health News:President Barack Obama Joins President George H.W. Bush to Celebrate the 20th Anniversary of the 'Points of Light' Volunteer Movement and Extend the Call of Service to the Nation 4Health News:President Barack Obama Joins President George H.W. Bush to Celebrate the 20th Anniversary of the 'Points of Light' Volunteer Movement and Extend the Call of Service to the Nation 5Health News:President Barack Obama Joins President George H.W. Bush to Celebrate the 20th Anniversary of the 'Points of Light' Volunteer Movement and Extend the Call of Service to the Nation 6Health News:News In Red and Blue: How Messages About Social Factors and Health Can Backfire 2Health News:News In Red and Blue: How Messages About Social Factors and Health Can Backfire 3
Irrigating nucleus chopper, tip angled 30 to side wedge shaped inferior edge with blunt tip and front notch for engaging iris end opening, 19 gauge. For use in the right hand....
Irrigating nucleus chopper, wedge-shaped inferior edge with, blunt tip, 0.6 mm dual sideports, 20 gauge....
Irrigating nucleus chopper, semi-sharp, wedge shaped inferior edge with a pointed tip, dual sideports, 20 gauge. For Phakonit cataract surgery....
Phaco chopper elongated Kuglen style push-pull tip with wedge shaped superior and inferior edges. For bi-directional chopping....
Medicine Products: