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:11/26/2014)... OH (PRWEB) November 25, 2014 Miles ... has joined the Graphel Carbon Products team as Sales/Marketing ... sales, marketing, and customer service for the graphite industry. ... Miles to our team,” stated Dave Trinkley, VP of ... “His wide range of experience in the graphite industry, ...
(Date:11/26/2014)... Dallas, Texas (PRWEB) November 26, 2014 ... Acid Industry is an in-depth research report on ... analysis, the report introduces Palmitic Acid, basic information, ... overview, policy analysis, and news analysis, etc. ... report analyzes Palmitic Acid market in ...
(Date:11/26/2014)... Theravalues Corporation annuncia con orgoglio il lancio di Theracurmin® ... Europe 2014 (dal 2 al 4 dicembre, ... con la maggiore biodisponibilità di sempre, con una combinazione ... norme europee. La curcumina è un pigmento ... longa ) che è stata associata con attività antiossidanti, ...
(Date:11/24/2014)... UAE, November 24, 2014 Five ... Bin Rashid Al Maktoum Awards for Medical Sciences", in ... Dubai, United Arab Emirates , on 15 December ... , The Carter Center which won the ... actively involved in numerous programs that aim to improve ...
Breaking Biology Technology:Miles Holder Joins Graphel Corporation as Sales/Marketing Manager 2Palmitic Acid Industry Global 2014 Analysis & 2020 Forecasts on Market data, Statics, Development Now at ReportsnReports.com 2Palmitic Acid Industry Global 2014 Analysis & 2020 Forecasts on Market data, Statics, Development Now at ReportsnReports.com 3La curcumina con la maggiore biodisponibilità di sempre farà il suo debutto in Europa 2La curcumina con la maggiore biodisponibilità di sempre farà il suo debutto in Europa 3Five US Winners Among Recipients of Hamdan Medical Awards 2
... Strategic Fund L.P. invests $10 million in Radius-, ... ("Radius"),announced today that it has granted Novartis (NYSE: ... worldwide license (except Japan) to develop and,commercialize all ... a proprietary analog of hPTHrP (human parathyroid,hormone-related protein) ...
... ultraviolet laser light has been used for years to ... extent of their thermal motion. Now, applying a different ... the National Institute of Standards and Technology (NIST) have ... miniature mechanical oscillator containing more than a quadrillion atoms, ...
... ST. LOUIS, Sept. 14 Sigma-Aldrich Corporation,(Nasdaq: SIAL ... Life Sciences,Conference on Tuesday, September 25th at 1:00 PM ... via live audio broadcast over the,Internet available at ... this file. For the webcast on, http://ir.sigmaaldrich.com users ...
Cached Biology Technology:Radius Grants Major Pharmaceutical Company Exclusive Option to License BA058 for Osteoporosis 2'Radio wave cooling' offers new twist on laser cooling 2
(Date:11/5/2014)... biology in the UTSA College of Sciences, is ... to receive a two-year $300,00 National Science Foundation ... The funding supports President Obama,s BRAIN Initiative, a ... technology that will demystify complex brain processes. ... are broken into the interactions of multiple components, ...
(Date:11/5/2014)... Brazil -Individuals show great diversity in their ability to ... females greatly differ in their perceptual evaluation of odors, ... tests. , Sex differences in olfactory detection ... may be connected to one,s perception of smell, which ... women,s olfactory superiority has been suggested to be cognitive ...
(Date:11/4/2014)... amount of death at the right time might actually ... research that could help in understanding animal populations, pest ... a paper in the journal Trends in Ecology ... colleagues conclude that the kind of positive population effect ... or mortality, depends on the size and developmental stage ...
Breaking Biology News(10 mins):UTSA biology professor awarded $300,000 NSF grant for brain research 2UTSA biology professor awarded $300,000 NSF grant for brain research 3The female nose always knows: Do women have more olfactory neurons? 2When less is more: Death in moderation boosts population density in nature 2
... featuring lab tours and scientific presentations on a variety ... medical countermeasures, vaccine adjuvant safety, and salmonella. Tailor your ... story ideas and spot news announcements on both days ... Margaret A. Hamburg, M.D., FDA Chief Scientist Jesse Goodman, ...
... , Johns Hopkins researchers have created a synthetic protein that, ... within the body where cancer, arthritis and other serious medical ... a new type of diagnostic imaging technology and may someday ... the body where signs of disease have been found. In ...
... mood for food can be changed by a restaurant,s choice ... calorie intake, according to a new study., "When we did ... music and lighting led diners to eat 175 fewer calories ... Wansink, professor of marketing and director of Cornell University,s Food ...
Cached Biology News:FDA's 2012 Science Writers Symposium 2Collagen-seeking synthetic protein could lead doctors to tumor locations 2Collagen-seeking synthetic protein could lead doctors to tumor locations 3
Collected from animals of U.S. origin.Collected from animals of U.S. origin. *Can be used in cell growth studies and immunoassays. *Sterility tested, * Mycoplasma tested upon request, *Endoto...
...
Mouse monoclonal [Ley 37D/G6] to LKB1 ( Abpromise for all tested applications). entrezGeneID: 6794 SwissProtID: Q15831...
... reagent for Virus isolation ... unique water insoluble Elastomeric ... and chaotropes; Engineered to ... viruses while preserving infectivity; ...
Biology Products: