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:9/1/2014)... is a leading review website in the world. It ... announced that GreenGeeks, Arvixe and Hostgator are the best ... http://www.greengeeks.com/cgi-bin/affiliates/clickthru.cgi?id=seohosts ) is one of the best web hosting ... of useful products for sale. On its website, customers ... , As one of the Top 10 Web Hosting ...
(Date:9/1/2014)... Television shows filled with action and sound may be ... cookies, carrots and grapes while watching an excerpt from ... program. , , Television has been blamed for helping ... lifestyle. But the focus of why has been on ... other distracting activities that can cause people to eat ...
(Date:9/1/2014)... News) -- You may be able to convince your brain ... suggests. The study included eight overweight and obese people ... to change how people react to different foods. These participants ... obese people who weren,t in the program. Both groups ... and again six months later. The scans revealed that the ...
(Date:9/1/2014)... (PRWEB) September 01, 2014 An operating ... a hospital for performing surgical operations. An operating room ... tables, surgical booms, operating room lights, imaging displays as ... a report by Transparency Market Research, a U.S.-based market ... to reach USD 4.5 billion by 2019. , ...
(Date:9/1/2014)... Dennis Thompson HealthDay ... An experimental Ebola drug previously given to two American aid ... deadly virus in laboratory tests, researchers report. The drug, ... even if they didn,t get the medication until five days ... of Ebola who were days or even hours away from ...
Breaking Medicine News(10 mins):Health News:The Best Reseller Hosting Suppliers in August Released by Leading Review SiteTop10BestSEOHosting.com 2Health News:Research letter: Viewers ate more while watching Hollywood action flick on TV 2Health News:Train Your Brain to Choose Fruit Salad Over French Fries 2Health News:Operating Room Equipment Market Study 2019 by Transparency Market Research 2Health News:Operating Room Equipment Market Study 2019 by Transparency Market Research 3Health News:Monkey Trial Supports Ebola Drug That May Have Helped 2 Stricken Americans 2Health News:Monkey Trial Supports Ebola Drug That May Have Helped 2 Stricken Americans 3
... to develop the colorectal polyps that can precede colon cancer. ... patients attending for colonoscopy. They found the incidence of polyps// ... cancer - to be greater among current smokers than in ... likely to have more than two polyps, growths greater than ...
... of the antioxidant vitamin E may assist in reducing ... Health Study and the Health Professionals Follow-Up Study', presented by ... Parkinson's disease. The participants have been followed up for several ... ,Those with a high intake of vitamin E ...
... UK inserting a coil into a weakened blood vessel offers ... rate from subarachnoid haemorrhage// - caused by a bursting of ... to 40 per cent in the first 24 hours after ... a clip to prevent further rupture of the blood vessel. ...
... medical centers hope to arbitrate whether a laser can stop ... two forms of macular degeneration, wet and dry. //The dry ... by the formation of yellowish deposits within the layers of ... have a gradual loss of vision. While there are a ...
... researchers of University of Kansas it is observed that poorly ... pain, gas and diarrhea.// Often people suffer from bowel symptoms ... can be found. They have found out that a high ... to digest fructose. ,Found in honey, fruits and ...
... that endometriosis is linked to infertility. There has long ... shows one of the reasons why the disease may ... patients, but concluded that endometriosis causes a certain action ... fluid located near the fallopian tubes. They then studied ...
Cached Medicine News:
(Date:8/29/2014)... YORK , Aug. 29, 2014 Pomerantz ... TMS S.A. ("EDAP" or the "Company") (NASDAQ: EDAP ... filed in United States District Court, Southern District of ... 14-cv-6069, is on behalf of a class consisting of ... February 1, 2013 and July 30, 2014, inclusive (the ...
(Date:8/29/2014)... PARK, Calif. , Aug. 29, 2014 ... Medical as CEO and member of the Board of ... decades of medical device development and commercialization experience, including ... field. Mr. Engelson previously served as a Partner of ... as President and CEO of two Foundry start-ups. Mr. ...
(Date:8/29/2014)... , Aug. 29, 2014 Research ... "China Orthopedic Instrument Industry Report, 2014-2017" report ... aging population and rising proportion of reimbursement for medical ... effectively released, with its scale presenting a CAGR of ... products are three product segments of orthopedic instruments in ...
Breaking Medicine Technology:SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against EDAP TMS S.A. and Certain Officers - EDAP 2SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against EDAP TMS S.A. and Certain Officers - EDAP 3Medina Medical Announces Erik T. Engelson Joins as Chief Executive Officer 2China Orthopedic Instrument Industry Report, 2014-2017 2
... Digital Assent, provider of the award-winning PatientPad® self-service ... that it has appointed Frank Garland as vice president ... Garland will focus on increasing the digital advertising and ... the company,s New York sales office. "Frank ...
... Oct. 20, 2011 Bend Research Inc. ( www.bendresearch.com ... has announced that John McLeod has joined the company ... http://photos.prnewswire.com/prnh/20111020/CL87178 ) McLeod was formerly Director ... six years, where his strategic vision is credited with ...
Cached Medicine Technology:Digital Assent Names Frank Garland Vice President of Advertising Sales 2Bend Research Announces New Chief Financial Officer 2
This is the second generation of the famous A/O sliding microtome, manufactured in the United States under the Leica trademark....
... base sliding microtome offers the ultimate in ... not least, safety. ,Designed to meet the ... 8000 will also meet the more demanding ... versatility and wide range of accessories will ...
... MNL 440601 Small Sledge Microtome is ideal for ... or skin specimens. Specimen rise is automatic ... 30 microns in increments of 2 microns. ... Stages.,Other Associated Products, Vibratomes Freezing Stages ...
... is a solid solution for setting ... the Vibratome Plus, standard accessory kit, ... mounts w/1/2" head, and a rotating ... of your sectioning needs.,For selection assistance, ...
Medicine Products: