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

/a>.

About EXPAREL™

EXPAREL is Pacira's proprietary drug candidate consisting of bupivacaine encapsulated in DepoFoam®, both of which are currently used separately in FDA-approved products. Bupivacaine is a well-characterized anesthetic/analgesic that has an established safety profile with more than 20 years of use in the United States. Market data indicate that there is an unmet medical need for a longer-acting anesthetic/analgesic for postsurgical pain management. Several Phase 2 and Phase 3 clinical trials have been completed for EXPAREL and suggest statistically significant reduction of pain in soft tissue and orthopedic surgery in different surgical models. Clinical data from Phase 3 trial 316 suggest that EXPAREL provides analgesia for up to 72 hours post-surgery, the primary endpoint for the trial. The safety of EXPAREL was evaluated in 10 randomized, double-blind, local administration into the surgical wound clinical studies involving 823 patients; the most common adverse events following EXPAREL administration were nausea, constipation, and vomiting.  

Forward Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about EXPAREL's potential, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the timing of, and our ability to obtain regulatory approval of EXPAREL; the timing of our anticipated commercial launch of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our commercializ
'/>"/>

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:7/11/2014)... Neurelis, Inc. ("Neurelis") today announced an agreement ... held by Biotie to purchase Neurelis, clearing the way ... diazepam) for pediatric and adult epilepsy patients who experience ... Biotie has advanced the development program for NRL-1 and ... work required for NDA submission to the FDA.  Given ...
(Date:7/10/2014)... July 10, 2014  Breg, Inc., a premier ... launched the FreeRunner™ knee brace with new innovations ... patella mal-tracking return to active lifestyles.  FreeRunner,s patent-pending ... braces, providing support when patients need it most, ... don,t. Patellofemoral issues are the most ...
(Date:7/10/2014)... , July 10, 2014  BC Technical, the ... MiE America , Inc., a leading provider of ... into a long-term agreement naming BC Technical as the ... MiE and BC Technical announced today ... to establish BC Technical as the service and systems ...
Breaking Medicine Technology:Neurelis Regains Rights to Intranasal Diazepam Program 2Neurelis Regains Rights to Intranasal Diazepam Program 3Breg Introduces Knee Brace to Help Runners with Patellofemoral Pain Syndrome 2BC Technical Partners With MiE America To Be Authorized Provider Of Systems & Service 2
... 20, 2011 Ann Arbor SPARK recently celebrated the conclusion ... and a reception.  At the Ann Arbor SPARK Boot Camp ... Boot Camp" winner, based on the quality of its investor ... engagement though the Ann Arbor SPARK Business Accelerator.   ...
... HYDERABAD, India, May 20, 2011 Neuland Laboratories Ltd., ... (APIs), complex intermediates, and contract research and manufacturing services ... results for the 2011 fiscal year (FY) ended March ... report that in fiscal year 2011, Neuland delivered on ...
Cached Medicine Technology:Brio Device Awarded Best of Ann Arbor SPARK's Boot Camp 2Neuland Labs Reports Financial Results for Fiscal Year 2011 2
(Date:7/13/2014)... By Serena Gordon ... -- A new type of sensor for people with ... body using saliva instead of blood, researchers report. Scientists ... successfully tested it using artificial saliva. It uses light, metal ... blood sugar. "Everybody knows that diabetics have to prick ...
(Date:7/13/2014)... York, New York (PRWEB) July 13, 2014 ... lawsuits ( http://www.transvaginalmeshlawsuithelp.com/ ) filed against Johnson ... litigation’s second bellwether trial, which is expected to get ... Order issued in the U.S. District Court, Southern District ... Conference will be held on August 7, 2014 at ...
(Date:7/13/2014)... July 13, 2014 Recently, MyDressCity.com, one ... women’s special occasion outfits, has released its new range ... the new products are available at discounted prices. Worldwide ... 2014. , In the company’s online shop, there ... of them are made with great materials. MyDressCity.com’s hot ...
(Date:7/13/2014)... A noninvasive optical imaging device developed at Cedars-Sinai ... occur in the brain and are a classic ... from investigators conducting a clinical trial in Australia. ... 15 in an oral presentation at the Alzheimer,s ... also were invited by conference organizers to participate ...
(Date:7/13/2014)... OH (PRWEB) July 13, 2014 Wright ... bellwether trial has been scheduled in July of 2015, ... Lipitor lawsuits are in the discovery process ... Richard M. Gergel is presiding over the multidistrict litigation ... filed on behalf of individuals who allege that they ...
Breaking Medicine News(10 mins):Health News:Saliva Test Might Someday Replace Needle Prick for Diabetics 2Health News:Saliva Test Might Someday Replace Needle Prick for Diabetics 3Health News:Ethicon Vaginal Mesh Lawsuits Move Forward, As Federal Court Schedules Pretrial Conference for Second Bellwether Case, Bernstein Liebhard LLP Reports 2Health News:Ethicon Vaginal Mesh Lawsuits Move Forward, As Federal Court Schedules Pretrial Conference for Second Bellwether Case, Bernstein Liebhard LLP Reports 3Health News:Ethicon Vaginal Mesh Lawsuits Move Forward, As Federal Court Schedules Pretrial Conference for Second Bellwether Case, Bernstein Liebhard LLP Reports 4Health News:Cheap Elegant Quinceanera Dresses Unveiled by MyDressCity.com 2Health News:Study of noninvasive retinal imaging device presented at Alzheimer's conference 2Health News:Study of noninvasive retinal imaging device presented at Alzheimer's conference 3Health News:Lipitor Lawsuits Move Forward With Scheduling Of First Bellwether Trial 2Health News:Lipitor Lawsuits Move Forward With Scheduling Of First Bellwether Trial 3Health News:Lipitor Lawsuits Move Forward With Scheduling Of First Bellwether Trial 4
... provides concierges companionship that goes beyond caretaking, ... Angel(TM) Inc., a,new company that provides individualized care ... it will launch its most,innovative service for providing ... concierges who will provide engaging one-on-one experiences for,seniors ...
... Celebrate YMCA Healthy Kids Day Saturday, April ... HILL, Calif., April 11 The Mt. Diablo Region,YMCA will ... YMCA,Healthy Kids Day on Saturday, April 12 from 9 a.m. ... and Irvin Deutscher Family YMCA.,An opportunity for kids and families ...
... Call Scheduled for 8:30 a.m. ET, ORANGE COUNTY, ... ) announced today it will host a conference call ... discuss the company,s first,quarter 2008 results. Earnings will be ... The call may be accessed by dialing (877) ...
... least surprised when researchers got paid but more upset ... News) -- Many volunteers in clinical studies aren,t overly ... some loss of trust, suggests a U.S. study. , ... clinical trial did not suffer substantially based on the ...
... NEW YORK, April 11 Takeda,Pharmaceutical Company Limited ... cash tender offer for all outstanding shares of ... for US$25.00 per share. The tender offer is ... subsidiary of Takeda America Holdings,Inc., which is a ...
... was,issued today by the Joint Center for Political ... for Political and Economic Studies in,collaboration with California ... Latino Elected and Appointed Officials (NALEO) will,conduct a ... and Why,They are Integral to Health Equity" during ...
Cached Medicine News:Health News:Send Me An Angel(TM) Pairs Senior Citizens With Their Peers in Alternative Care 2Health News:Send Me An Angel(TM) Pairs Senior Citizens With Their Peers in Alternative Care 3Health News:The Mt. Diablo Region YMCA Invites Families to 'Put Play in Your Day' and Bring Healthy Habits Home During the Nation's Largest Health Day for Children and Families 2Health News:The Mt. Diablo Region YMCA Invites Families to 'Put Play in Your Day' and Bring Healthy Habits Home During the Nation's Largest Health Day for Children and Families 3Health News:Beckman Coulter Announces First Quarter 2008 Earnings to be Released on Wednesday, April 30, 2008, Before Market Opens 2Health News:Clinical Trial Volunteers Uneasy About Some Financial Ties 2Health News:Takeda Commences Cash Tender Offer for all Outstanding Shares of Millennium 2Health News:Takeda Commences Cash Tender Offer for all Outstanding Shares of Millennium 3Health News:Joint Center to Focus on Issues of Health Equity During Congressional Black Caucus Spring Health Braintrust 2
The Pach IV is the premier product for cornea thickness measurement in conjunction with Glaucoma screening....
Inquire...
... Immunosorbent Assays(ELISA) is intended for the detection ... Measles Rubeola) virus in human sera. Individual ... determination of immune status. Paired sera, acute ... or a significant rise in antibody as ...
Measles IgM ELISA test is an enzyme linked immunosorbent assay (ELISA) for the detection of IgG class antibodies to Measles (Rubeola) in human serum or plasma....
Medicine Products: