Navigation Links
Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for KRYSTEXXA(TM)
Date:8/2/2009

0. We hope to have more clarity on the expected timeline after we meet with the FDA to discuss the complete response letter," stated Paul Hamelin, President of Savient Pharmaceuticals. "While we believe we have made substantial progress toward the potential final approval of KRYSTEXXA, we also have more work to do with the FDA to resolve these open issues. We are committed to work diligently to address these issues with a goal of obtaining final approval for KRYSTEXXA so we can provide this therapy to those chronic gout patients who are suffering from this crippling, debilitating disease and have no other treatment options."

The Company believes that its resubmission will respond to all of the deficiencies cited in the compete response letter and would lead to a new Prescription Drug User Fee Act expected action date of either two or six months after the date of the Company's resubmission, depending on the FDA's classification of the resubmission.

ABOUT KRYSTEXXA(TM)

KRYSTEXXA(TM) (pegloticase) is a PEGylated uricase enzyme intended for the treatment of chronic gout in patients refractory to conventional therapy. Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

Conference Call Information

Savient will host a live webcast to discuss the approval of KRYSTEXXA on August 3, 2009 at 8:00 a.m. Eastern Time. Both the live and archived webcast can be accessed from the Investor Relations page of Savient's Website at http://www.savient.com. A digital recording of the webcast will be available within one hour following the conclusion of the c
'/>"/>

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

Page: 1 2 3 4 5 6

Related medicine news :

1. Savient Pharmaceuticals to Present at the Credit Suisse Phoenix Healthcare Conference on November 13th
2. Savients Board of Directors Forms a Board Committee to Oversee the Regulatory and Pre-Launch Activities for Pegloticase
3. Savient Pharmaceuticals to Present at the 27th Annual J.P. Morgan Healthcare Conference on January 14th
4. Savient Pharmaceuticals Reports Fourth Quarter and Year-End 2008 Financial Results
5. Savient Pharmaceuticals to Present at The Cowen and Company 29th Annual Healthcare Conference on March 17, 2009
6. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
7. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
8. Provectus Pharmaceuticals, Inc. Begins Phase 2 Clinical Trial for Metastatic Melanoma
9. Idenix Pharmaceuticals to Present at Two Upcoming Investor Conferences
10. Vista Partners Updates Coverage on Tapestry Pharmaceuticals
11. Transcept Pharmaceuticals, Inc. to Present at UBS 2007 Global Life Sciences Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... made from the wonder material graphene has been used ... developing cancer. , The biosensor has been shown ... bioassay tests currently in use, and was able to ... the possibility of a rapid, point-of-care diagnostic tool for ... September, in IOP Publishing,s journal 2D Materials . ...
(Date:9/19/2014)... 2014 Follow us on LinkedIn ... medical imaging market, are engineered to enhance the anatomic ... past three decades have expanded the application roles of ... based agents used for over half a century to ... agents have witnessed sea changes, revolutionizing in the process ...
(Date:9/19/2014)... 2014 The Nordic ... style of eating, is making its way ... Doc’s medical weight loss programs, ... good food which leads to improved health. ... patients to understand how diet can impact ...
(Date:9/19/2014)... Recent financial data reveled ... their sales by 7% in the last quarter of ... can be used as a bellwether to determine how ... data has been proven to show trends with shipments ... Other non-trucking data is largely influenced by international and ...
(Date:9/19/2014)... Baltimore, MD & Salt Lake City, UT (PRWEB) September ... pleased to launch the new Activz Greens Smoothie ... Natural Products Expo East, September 18th-20th in Baltimore, ... powder with 8 organic super foods combined in one ... at Natural Products Expo East, September 18th-20th in Baltimore, ...
Breaking Medicine News(10 mins):Health News:Graphene sensor tracks down cancer biomarkers 2Health News:New Clinical Applications and Advanced Imaging Capabilities Drive Growth in the Imaging Agents Market, According to New Report by Global Industry Analysts, Inc. 2Health News:New Clinical Applications and Advanced Imaging Capabilities Drive Growth in the Imaging Agents Market, According to New Report by Global Industry Analysts, Inc. 3Health News:New Clinical Applications and Advanced Imaging Capabilities Drive Growth in the Imaging Agents Market, According to New Report by Global Industry Analysts, Inc. 4Health News:Diet Doc’s Medical Weight Loss Programs Announce Diet Plans Based on the Same Principles as the New Nordic Diet 2Health News:Diet Doc’s Medical Weight Loss Programs Announce Diet Plans Based on the Same Principles as the New Nordic Diet 3Health News:Diet Doc’s Medical Weight Loss Programs Announce Diet Plans Based on the Same Principles as the New Nordic Diet 4Health News:LeaseQ Announces Good News For The Truck Leasing Industry As Truck Rentals In The U.S Continues to Gain Traction 2Health News:LeaseQ Announces Good News For The Truck Leasing Industry As Truck Rentals In The U.S Continues to Gain Traction 3Health News:New Activz Greens Smoothie with 8 Organic Superfoods & More Launched at Natural Products Expo East 2Health News:New Activz Greens Smoothie with 8 Organic Superfoods & More Launched at Natural Products Expo East 3
... Jeffrey M. Bethony, Ph.D., associate professor of Microbiology, ... professor of Microbiology, Immunology, and Tropical Medicine at ... with colleagues from Khon Kaen University in Thailand ... an sensitive and specific biomarker for the detection ...
... being able to mathematically describe the process by which ... its every function, and dysfunction. Such capability holds enormous ... when and where things go developmentally awry and ... of breakthrough is one of the long-term goals of ...
... 29 (HealthDay News) -- Preventive antiretroviral treatment appears to ... against HIV infection, a new study suggests. HIV, ... unprotected sex and contaminated needles. Immediate treatment after ... previous research has found. More recently, several large randomized, ...
... Adrian Mulholland and Dr Christopher Woods from Bristol,s School ... processing units (GPUs) to simulate the molecular processes that ... the H1N1-2009 strain of influenza commonly known as ... in Biochemistry , provide new insight that could ...
... disorders have uncovered insights into those diseases in ... Focusing on the cohesin complex, a group of ... scientists have discovered mutations that disrupt cohesin, causing ... "We are learning more about how these ...
... This release is available in German . ... to establish 20 Collaborative Research Centres (CRCs) by 1 July ... its spring session in Bonn. The new CRCs will receive ... allowance for indirect project costs) for the initial 4-year funding ...
Cached Medicine News:Health News:GW researchers discover biomarker for advanced bile duct fibrosis and bile duct cancer 2Health News:UC Santa Barbara's Kavli Institute receives 2 grants to explore interface of physics and biology 2Health News:UC Santa Barbara's Kavli Institute receives 2 grants to explore interface of physics and biology 3Health News:Taking Anti-HIV Meds Prior to Exposure May Help Prevent Infection 2Health News:New study shows why swine flu virus develops drug resistance 2Health News:Mutations impair childhood growth and development by disrupting organization of chromosome pairs 2Health News:DFG establishes 20 new Collaborative Research Centres 2Health News:DFG establishes 20 new Collaborative Research Centres 3Health News:DFG establishes 20 new Collaborative Research Centres 4Health News:DFG establishes 20 new Collaborative Research Centres 5Health News:DFG establishes 20 new Collaborative Research Centres 6
(Date:9/19/2014)... , Sept. 19, 2014  Diplomat, the nation,s largest ... David Dreyer to the Board of Directors on ... and will also serve as chair of the Audit ... years of accounting, financial, compliance and operating experience in ... has served as chief financial officer, chief operating officer ...
(Date:9/19/2014)... Sept. 19, 2014 Larry J. Merlo , ... ), will speak before the National Press Club in ... company,s recent move to stop selling tobacco products and its ... of health. "Dramatic changes in our health care ... and government," Merlo has said. "CVS Health has a truly ...
(Date:9/19/2014)... 19, 2014  Pressure BioSciences, Inc. (OTCQB: PBIO) ... received and approved all parts required to build ... begun to manufacture the new PCT-based instrument system.  ... ready for shipment by mid-October and that additional ... a rate of about one per week thereafter.  ...
Breaking Medicine Technology:David Dreyer Appointed to Diplomat Board of Directors 2CVS Health CEO to Address National Press Club on Landmark Decision to Quit Tobacco, Leadership in Health Care Innovation 2CVS Health CEO to Address National Press Club on Landmark Decision to Quit Tobacco, Leadership in Health Care Innovation 3Pressure BioSciences Announces Completion of the First Phase of Its Commercialization Plan for the Barozyme HT48, the Company's Recently Released High Throughput PCT-based Instrument System 2Pressure BioSciences Announces Completion of the First Phase of Its Commercialization Plan for the Barozyme HT48, the Company's Recently Released High Throughput PCT-based Instrument System 3
... CHICAGO, March 7, 2012  UHC, an alliance of the ... of a mobile application for Rx LINK ™ , ... insight into their pharmacy price performance. The mobile app ... can be accessed on an Apple iPad. ...
... Drug Discovery Foundation (ADDF) and the Association for ... their fifth annual research award, Frontotemporal Degeneration ... of the program is to accelerate the development ... The ADDF/AFTD program awarded $300,000 to ...
Cached Medicine Technology:UHC Launches RxLINK(TM) Mobile App to Deliver Instant Data Access for Strategic Pharmacy Purchasing 2UHC Launches RxLINK(TM) Mobile App to Deliver Instant Data Access for Strategic Pharmacy Purchasing 3Awards for Drug Discovery Research for Frontotemporal Degeneration Announced 2Awards for Drug Discovery Research for Frontotemporal Degeneration Announced 3
Used for placement of choledochoscopes, cholangiography catheters and other instruments. Supplied sterile in peel-open packages. Intended for one-time use....
Used for common bile duct exploration. Supplied sterile in peel-open packages. Intended for one-time use....
... Marker directly to the biopsy site helps ... performed. ,The MICROMARK® II Tissue Marker is ... for use with the MAMMOTOME Biopsy System. ... site after a biopsy with the MAMMOTOME ...
... A biopsy with the ... an effective, minimally invasive procedure ... patient management.,Using computer-generated images to ... more accurately pinpoint and map ...
Medicine Products: