Navigation Links
Savient Provides Update on Meeting with U.S. Food and Drug Administration for KRYSTEXXA(TM)
Date:9/16/2009

corrected ahead of its resubmission to the FDA in response to the CRL.

The FDA also stated that the format and content of Savient's proposed safety update, which will include additional data collected from the KRYSTEXXA Open Label Extension study, is acceptable to the FDA.

During the meeting, the Company was informed that the review cycle for the resubmission would include the review of all data to fully address all issues identified in the CRL, including the final product labeling and the REMS materials. Since the resubmission will include REMS materials, this is subject to a Class 2 review cycle, meaning simultaneous approval of all components of our filing within six months of the date of our resubmission.

"We look forward to continuing to work with the FDA and executing on our resubmission strategy to the Complete Response Letter so that we can move forward with delivering this important therapy to treat chronic gout patients who are suffering from this crippling, debilitating disease and who have no other treatment options," commented Mr. Hamelin.

Savient also stated that the official minutes of this Type A meeting with the FDA will be made available to the Company within approximately 30 days from the date of the meeting.

Conference Call Information

Savient's management team will host a live conference call and Webcast today at 9:00 a.m. Eastern Time/6:00 a.m. Pacific Time to further discuss the results of the Type A meeting with the FDA. To participate by telephone, please dial 888-349-9587 from the U.S. or 719-457-2640 for international callers. The conference identification number is 8540659. The live and archived Webcast can be accessed on the investor relations section of the Savient Website at www.savient.com. Please log on to Savient's website
'/>"/>

SOURCE Savient Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related biology technology :

1. Savient Announces New Date for FDA Arthritis Advisory Panel Review of KRYSTEXXA(TM) for Treatment Failure Gout
2. Savient Pharmaceuticals Reports First Quarter 2009 Financial Results
3. Savient Pharmaceuticals to Raise $31 Million Through Registered Direct Offering
4. Savient Pharmaceuticals to Hold Fourth Quarter and Year-End 2008 Results Conference Call on Thursday, February 26, 2009
5. Savient Announces Appointment of David Gionco as Chief Financial Officer
6. Savient Pharmaceuticals to Present at the Lazard Capital Markets 5th Annual Healthcare Conference on November 18th
7. Savient Pharmaceuticals Reports Third Quarter 2008 Financial Results
8. Savient Submits Biologics License Application (BLA) for pegloticase
9. Savients Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology Conference
10. Savient Pharmaceuticals to Hold Third Quarter 2008 Financial Results Conference Call on Thursday, November 6, 2008
11. Access Pharmaceuticals Provides Update on ProLindac(TM)Clinical Development Plan
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2015)... ... July 31, 2015 , ... R-Biopharm is proud ... partially hydrolyzed gluten in foods, has been accepted by AOAC International as Official ... Gluten in Fermented Cereal-Based Products by R5 Competitive ELISA,” based on a specific ...
(Date:7/30/2015)... ... ... The 2015 Market Research Report on the Global Propanol Industry ... market with a focus on the Chinese situation. Major companies included in the propanol ... Sanofi, Royal Dutch Shell, LG Chem and Zhejiang Xinhua Chemical. , The report provides ...
(Date:7/30/2015)... , July 30, 2015  With over 60,000 customers across the globe, ISN ... connect 450 hiring organizations with more than 60,000 safe and reliable contractors in over 80 countries. ... ... ... Headquartered in Dallas, TX ...
(Date:7/30/2015)... ... 2015 , ... GEA's Pony™ NS2006L is a ... to 1500 bar. The sanitary design gauge of the NS2006L is well suited ... Pony™ NS2006L homogenizer is an ideal solution for the processing of nanoparticles, ...
Breaking Biology Technology:RIDASCREEN® Competitve Gliadin Receives AOAC Official First Action Status 2Global Propanol Market Technical Data and Manufacturing Analysis 2020 2Global Propanol Market Technical Data and Manufacturing Analysis 2020 3ISN Reaches Over 60,000 Worldwide Customers 2ISN Reaches Over 60,000 Worldwide Customers 3GEA Announces the Pony™ NS2006L… a Self-contained, High Pressure Lab Homogenizer for Product Development Ensuring Maximum Efficiency and Safety 2
... Jan. 10, 2012 Saladax Biomedical, Inc., a privately ... achieve the promise of personalized medicine for new and ... six patents within the last 12 months, bringing the ... which contain broad claims in the immunoassay space.  The ...
... Show) – iHealth Lab Inc., the pioneering designer and ... Blood Pressure Dock and iHealth Digital Scale today announced ... immediately when users download latest version of the companion ... Scale, the free service will enable users to instantly ...
... Solutions Inc. (OTCBB: BLFS), a leading developer, manufacturer, and ... freeze media for cells and tissues, today announced preliminary ... 2011. Highlights include: , Sixth consecutive quarter of record ... 13% over the third quarter and 41% over the same ...
Cached Biology Technology:Saladax Biomedical, Inc. Issued Six Patents Containing Broad Claims in the Immunoassay Space 2iHealth Lab Launches Personalized Web Portal to Store Your Vitals 2BioLife Solutions 2011 Revenue Up 33% 2BioLife Solutions 2011 Revenue Up 33% 3
(Date:7/30/2015)... 2015 Cellecta, Inc., a U.S.-based provider ... and biomarker discovery, announced the release of its ... all human protein coding genes. CRISPR technology enables ... gene,s function. Cellecta,s new Human Whole Genome CRISPR ... so that researchers can investigate in a single ...
(Date:7/21/2015)... 21, 2015 Today, ZTE announced its Android ... well as expected revenues in 2015 that relate to sales of ... guidance of approximately 2,200 MSEK for 2015. Jörgen Lantto, ... smartphone manufacturer in China and we are ... 5 for Axon , its ...
(Date:7/13/2015)... Jul. 13, 2015 NXT-ID, Inc. (NASDAQ: ... authentication company focused on the growing mobile commerce ... patent 62/188684 for BEHAVIORAL-DIRECTED AUTHENTIATION METHOD ... convenient and secure method to make payments.  With ... methods, introduced with its groundbreaking voice-direct payment patent ...
Breaking Biology News(10 mins):CELLECTA, INC. Announces Launch of Human Whole Genome CRISPR Knockout Library 2FPC's Touch Fingerprint Sensor FPC1025 in ZTE's Smartphone Axon 2NXT-ID Patents Behavior-Directed Payments 2NXT-ID Patents Behavior-Directed Payments 3NXT-ID Patents Behavior-Directed Payments 4
... genetic variant that substantially improves survival of individuals with ... disease, has been indentified by a consortium of researchers ... and Robert Brown, MD, DPhil, Chair and Professor of ... of the KIFAP3 gene variant is reported in the ...
... in avian conservation is underway this spring throughout the ... A legion of highly skilled volunteer ornithologists is helping ... sites for migrating birds in the southern coastal zone ... migrants. These songbirds summer in the subarctic part of ...
... Lyncean Technologies, Inc. has just received a Phase ... Center for Research Resources (NCRR) to develop "Differential ... produced by the Compact Light Source (CLS). ... ongoing development of the Compact Light Source and ...
Cached Biology News:UMMS researchers isolate first 'neuroprotective' gene in patients with amyotrophic lateral sclerosis 2Conservationists seek to identify prime stopover sites for migrating birds 2Conservationists seek to identify prime stopover sites for migrating birds 3Lyncean Technologies Inc. receives $1.2 M from NCRR to develop new imaging technique 2
...
TNM-FH Insect Medium 1 liter...
IHC Polymer Detection Kit (Rabbit DAB)150 slides...
Performance, mycoplasma, virus, and endotoxin tested. Collected from calves 14 days old or less...
Biology Products: