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:11/27/2014)... In order to enable people to adapt to the ... way to avoid touching a toilet seat and/or lid while ... of the patent-pending Toilet Tamer, a device that enables a ... in a more sanitary manner. It avoids direct contact with ... promotes good hygiene and peace of mind. The portable device ...
(Date:11/27/2014)... 27, 2014 Now that Thanksgiving is ... officially launched, Emassagechair.com has announced its eagerly ... Event. , Negotiating on behalf of their customers, ... chair brands, Emassagechair.com has generated significant buzz in the ... biggest discounts yet. , Shoppers are excited for significant ...
(Date:11/27/2014)... VogueQueen.com is making every effort to offer more ... As the premier online supplier of elegant special occasion ... a huge selection of sexy prom dresses today. In ... providing many beautiful styles in its product line. Click ... prices. , “VogueQueen.com hopes to provide a truly unique ...
(Date:11/27/2014)... Developers and plugin specialist of Final Cut ... taking FCPX to the next level. , “ProPip allows users ... clicks of a mouse,” said Christina Austin, CEO of Pixel ... will appreciate.” , With ProPip users can show off their ... endless. ProPip is great for commentaries, news casting, and more. ...
(Date:11/27/2014)... November 27, 2014 HealthPostures, a ... ergonomics equipment , has announced that it has ... Office Environments. The partnership will put HealthPostures' products ... location. , In addition to having its products ... partnership promotes HealthPostures' products with the business decision ...
Breaking Medicine News(10 mins):Health News:Emassagechair.com is Excited to Announce Their Biggest Discount Event of the Year, Starting the Day After Thanksgiving and Lasting Through The Holiday Weekend. 2Health News:Emassagechair.com is Excited to Announce Their Biggest Discount Event of the Year, Starting the Day After Thanksgiving and Lasting Through The Holiday Weekend. 3Health News:Emassagechair.com is Excited to Announce Their Biggest Discount Event of the Year, Starting the Day After Thanksgiving and Lasting Through The Holiday Weekend. 4Health News:A New Collection of Sexy Prom Dresses Has Been Released by the Reliable Online Supplier VogueQueen.com 2Health News:Pixel Film Studios released ProPip plugin Exclusively for Final Cut Pro X 2Health News:Pixel Film Studios released ProPip plugin Exclusively for Final Cut Pro X 3Health News:Ergonomics Manufacturer Announces New Partnership with Office Supply Dealer 2
... and Development, RESTON, Va., Feb. 4 ... that Donald W. Hackett, chief executive,officer, has left ... Bruce Roberts, RPh, executive vice president and ... chairman of Mirixa,s board of,directors, expressed appreciation for ...
... May Help Protect Your Heart, LANSING, Mich., Feb. ... mantras for promoting heart-health during February,American Heart Month. But ... red to protect our hearts. Americans are encouraged to ... first-ever National,Eat Red Week, Feb. 4-10., Why eat ...
... OTTAWA, Feb. 4 Sports and,nutritional product ... http://www.naturalnutritioninc.com primary operating subsidiary,InterACTIVE Nutrition, ... increase,in 2007 revenues over the calendar year ... (CDN) versus 2007 unaudited revenues of $17,460,780,(CDN)., ...
... Simcere Pharmaceutical,Group (NYSE: SCR ), a leading ... anti-cancer pharmaceuticals in the rapidly,growing China market, announced ... quarter results on Tuesday, March 4, 2008 before ... executive officer, Jinsheng Ren, and,chief financial officer, Frank ...
... SAN ANTONIO, Feb. 3 Noticing a few extra hairs ... trying to conceal areas of,thinning hair rather than a fashion ... promoting hair growth? If you answered,yes to any of these ... some form of hair loss. But to whom should you ...
... prove anecdotes that canines can smell dangerous drops in blood ... researchers hope to prove that a dog,s keen sense of ... sugar levels of diabetics. , Canines have already shown themselves ... the physically disabled with daily tasks. , But researchers at ...
Cached Medicine News:Health News:Mirixa Corporation Announces Leadership Change 2Health News:Celebrate American Heart Month by Eating Red 2Health News:Celebrate American Heart Month by Eating Red 3Health News:Natural Nutrition Operating Subsidiary Reports Record 29% Increase in Revenues for 2007 of $17,460,000 2Health News:Simcere Pharmaceutical Group to Announce Fourth Quarter 2007 Earnings on Tuesday, March 4, 2008 2Health News:Don't Let Hair Loss Tangle You Up: Dermatologists Can Identify Common Hair Disorders and Offer Solutions 2Health News:Don't Let Hair Loss Tangle You Up: Dermatologists Can Identify Common Hair Disorders and Offer Solutions 3Health News:Don't Let Hair Loss Tangle You Up: Dermatologists Can Identify Common Hair Disorders and Offer Solutions 4Health News:Don't Let Hair Loss Tangle You Up: Dermatologists Can Identify Common Hair Disorders and Offer Solutions 5Health News:Don't Let Hair Loss Tangle You Up: Dermatologists Can Identify Common Hair Disorders and Offer Solutions 6Health News:Dogs Could Be a Diabetic's Best Friend 2Health News:Dogs Could Be a Diabetic's Best Friend 3Health News:Dogs Could Be a Diabetic's Best Friend 4
(Date:11/26/2014)... November 25, 2014 According ... by Power Source (Electric, Battery, Pneumatic), by Product ... Burr, Cart), by Application (Orthopedic, ENT, Oral, Thoracic, ... MarketsandMarkets, the global Powered Surgical Instruments Market is estimated ... in 2014 and is expected to grow at ...
(Date:11/26/2014)... 2014 Nanomix Inc., (Nanomix), a ... of mobile diagnostic tests to enable earlier ... pre-hospital settings, today announced it has received ... certification was awarded by the British Standards ... certification bodies. ISO 13485:2003 ...
(Date:11/26/2014)... THOUSAND OAKS, Calif. and LONDON ... AMGN ) and AstraZeneca (NYSE: AZN ) today ... trial evaluating two doses of brodalumab in more than 1,800 ... compared with both Stelara ® (ustekinumab) and placebo at ... the brodalumab weight-based analysis group were each shown to be ...
Breaking Medicine Technology:Powered Surgical Instruments Market Worth $2.1 Billion by 2019 2Powered Surgical Instruments Market Worth $2.1 Billion by 2019 3Powered Surgical Instruments Market Worth $2.1 Billion by 2019 4Nanomix Receives ISO 13485:2003 Certification 2Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 2Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 3Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 4Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 5Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 6Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 7Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 8Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 9Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 10
... N.J., Dec. 22, 2011  Ikaria, Inc. announced today that ... DS drug-delivery systems related to a fretting corrosion.  This ... direction of the U.S. Food and Drug Administration (FDA).  ... a reasonable likelihood of serious adverse health consequences or ...
... 2011 ViroPharma Incorporated (NASDAQ: VPHM ) today ... acquire Meritage Pharma, Inc., a private company based in San ... a treatment for eosinophilic esophagitis (EoE), a chronic inflammatory disorder ... initial $7.5 million, and has agreed to provide Meritage up ...
Cached Medicine Technology:Ikaria® Issues Notice of Completed Remediation for INOMAX® DS Drug-delivery System 2Ikaria® Issues Notice of Completed Remediation for INOMAX® DS Drug-delivery System 3ViroPharma Purchases Exclusive Option to Acquire Meritage Pharma 2ViroPharma Purchases Exclusive Option to Acquire Meritage Pharma 3ViroPharma Purchases Exclusive Option to Acquire Meritage Pharma 4ViroPharma Purchases Exclusive Option to Acquire Meritage Pharma 5ViroPharma Purchases Exclusive Option to Acquire Meritage Pharma 6ViroPharma Purchases Exclusive Option to Acquire Meritage Pharma 7
...
EDM Ventricular Drainage Kit, with Drip Chamber with and without Bioglide are fabricated of radiopaque (barium impregnated) silicone tubing, and are packaged with stainless steel stylets inserted in ...
Lumbar External Drainage System (LED) with Touhy needle is indicated for temporary access to the Lumbar Subarachnoid region as a means of draining cerebral spinal fluid (CSF) in order to reduce incre...
Monitorr ICP external CSF drainage and monitoring system with patient line one way valve....
Medicine Products: