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

EAST BRUNSWICK, N.J., Aug. 2 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that the Company has received a complete response letter from the U.S. Food and Drug Administration (FDA) stating that the FDA can not at this time approve the Company's Biologics License Application (BLA) for KRYSTEXXA(TM) (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy.

The complete response letter from the FDA cites deficiencies with the chemistry, manufacturing and controls (CMC) section of the BLA and also provided the current draft of the proposed labeling and further guidance regarding a Risk Evaluation and Mitigation Strategy (REMS) (Medication Guide and Communication Plan). The Company intends to immediately request a meeting with the FDA to discuss and clarify the issues raised in the complete response letter. Under FDA regulations, the Company believes that this meeting is deemed a "Type A" meeting, meaning that the FDA would meet with the Company within 30 days of its receipt of the meeting request.

One of the issues raised by the FDA in the complete response letter addresses a change made by the Company in the proposed process for manufacturing KRYSTEXXA for commercial use. The FDA has concluded that the comparability data submitted for the material manufactured using the proposed commercial manufacturing process was not adequate to demonstrate that it was representative of the material used to establish the safety and efficacy of KRYSTEXXA in its Phase 3 clinical trials. The FDA stated that the Company has the option of either reverting to and validating the manufacturing process used to produce KRYSTEXXA for the Phase 3 clinical trials or conducting additional comparability clinical trials to support the use of KRYSTEX
'/>"/>

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

3

GOOD

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:5/25/2013)... (PRWEB) May 25, 2013 Imagine running the ... the energy loss, hot air and wasted energy! If the ... fan, a fireplace or clothes dryer, that may be just ... from these often overlooked holes waste energy in the form ... heating and cooling loss in the home. , Drafts occur ...
(Date:5/25/2013)... not astonishing that holidays are amongst the most stressful ... family, friends and co-workers. Between the parties to attend, ... parents can afford, parties to arrange, and so much ... and it seems like an eternal cycle of gift ... income can’t catch up to the expenses of these ...
(Date:5/25/2013)... An experienced Chandler dentist has just launched ... Media Surge, LLC. , http://www.ChandlerDentalExcellence.com/Teeth-Whitening.php , ... on the treatment, can be performed in the office ... method will be chosen for the individual patient. , ... special peroxide-based whitening gel is used along with a ...
(Date:5/25/2013)... FL (PRWEB) May 25, 2013 Communities ... Worth, Texas. It is the fifth largest media market in ... is the number one visitor destination in Texas and a ... gateway to the American West as it is home to ... everyone will enjoy from sports to the arts. Residents and ...
(Date:5/25/2013)... New York, New York (PRWEB) May 25, 2013 ... a federal multidistrict litigation underway in U.S. District Court, ... Liebhard LLP reports. According to a Case Management ... procedures that govern the filing of contested motions in ... for filing those motions. (In re: Actos Product Liability ...
Breaking Medicine News(10 mins):Health News:How To Stop Drafts and Save On Home Energy Bills This Summer - New Draft Stoppers Now Available From Battic Door Energy Conservation 2Health News:How To Stop Drafts and Save On Home Energy Bills This Summer - New Draft Stoppers Now Available From Battic Door Energy Conservation 3Health News:How To Stop Drafts and Save On Home Energy Bills This Summer - New Draft Stoppers Now Available From Battic Door Energy Conservation 4Health News:TheBeautyPlace.com Debuts Their Brand New Beauty Kits 2Health News:Chandler Dentist Launches Teeth Whitening Service Page on Website in Partnership with JD Media Surge, LLC 2Health News:Communities of Distinction TV Presents May Air Dates for Dallas-Ft. Worth, Texas 2Health News:Actos Lawsuit News: Bernstein Liebhard LLP Notes New Case Management Order in Federal Actos Bladder Cancer Litigation 2Health News:Actos Lawsuit News: Bernstein Liebhard LLP Notes New Case Management Order in Federal Actos Bladder Cancer Litigation 3
... . , The PhD, defended by Ana ... Country, proposes a series of recommendations that contribute to ... treat terminal cancer patients. , Autonomy is the capacity ... knowledge about the causes of the illness, sufficient information ...
... Shared Health, Inc.,provider of secure health information ... Tennessee to provide its electronic health record,solutions ... health information,network called the Tennessee Information Network ... partnership with the State of Tennessee began ...
... The Providence Service,Corporation (Nasdaq: PRSC ) today announced ... fourth quarter and year ended December 31, 2007,on Wednesday, ... will hold a conference call at 11:00 a.m. EDT ... March 13, 2008 to discuss its,financial results and corporate ...
... Bowl champ O.J. Brigance,who recently confirmed a diagnosis ... The Robert Packard Center for ALS Research at ... the Center to fund,research to find a cure ... (Photo: http://www.newscom.com/cgi-bin/prnh/20080303/NEM042 ), The ...
... Faculty of 1000 Medicine, researchers look at the way ... used by physicians in Quebec. , The authors ... that general practitioners diagnosed 79% of the 10,001 rheumatoid ... a rheumatologist. Half of these patients were seen in ...
... study has found that elevated liver enzymes discovered ... future mortality. The findings are in the March ... Wiley & Sons on behalf of the American ... The article is also available online at Wiley ...
Cached Medicine News:Health News:Factors that enhance autonomy of cancer patients 2Health News:Factors that enhance autonomy of cancer patients 3Health News:Shared Health Partners With State of Tennessee to Provide Electronic Health Information for Statewide Health Information Network 2Health News:Providence Service Corporation to Report Fourth Quarter 2007 Results on Wednesday, March 12th After the Market Closes 2Health News:Providence Service Corporation to Report Fourth Quarter 2007 Results on Wednesday, March 12th After the Market Closes 3Health News:O.J. Brigance Named Honorary Chair of May 3 Race to Cure ALS, Confirms His Diagnosis by The Robert Packard Center for ALS Research at Johns Hopkins 2Health News:Elevated liver enzymes associated with higher future mortality 2
(Date:5/23/2013)... Hearing health affects a man,s lifestyle, and if he wants ... engaged, he should address any hearing loss he may be ... Hearing Institute (BHI) is delivering to men around the ... which leads up to and includes Father,s Day. This year, ... 16. To help men address their hearing ...
(Date:5/23/2013)... May 23, 2013  A recently published clinical study ... Houston, Texas , demonstrates that 3D mammography (breast ... detection. The study, "Implementation of Breast ... was led by Stephen L. Rose ... the American Journal of Roentgenology (AJR). The ...
(Date:5/23/2013)... -- Hadasit Bio-Holdings Ltd. (TASE: HDST, OTC: HADSY), a ... intellectual property developed and owned by Hadassah University ... research center, today announced that its portfolio company, ... the Israeli Ministry of Industry and Commerce, Office ... development and advance clinical trials. Cell Cure,s development ...
Breaking Medicine Technology:Men Who Want to Stay Active, Feel Younger, and Remain Socially and Professionally Engaged Should Address Hearing Loss, BHI Advises 2Men Who Want to Stay Active, Feel Younger, and Remain Socially and Professionally Engaged Should Address Hearing Loss, BHI Advises 3Men Who Want to Stay Active, Feel Younger, and Remain Socially and Professionally Engaged Should Address Hearing Loss, BHI Advises 4First Large-Scale U.S. Study Validates the Benefits of 3D Mammography (Breast Tomosynthesis) Exams 2First Large-Scale U.S. Study Validates the Benefits of 3D Mammography (Breast Tomosynthesis) Exams 3Hadasit Bio-Holdings Ltd. Portfolio Company - Cell Cure Neurosciences Ltd. Received Additional Government Support 2
... 400 is a sophisticated whole blood analysis ... testing while also satisfying the stringent requirements ... measurement cartridge contains all of the components ... cartridge includes the sampling unit, all of ...
248 is fully automated blood gas systems offering a cost-effective solution for critical care testing in settings with low to medium workloads....
Microcomputer controlled, preparative ultracentrifuge, with CFC-free refrigeration system. Available either internally cooled or with external water cooling. Quikset user interface, Softspin automati...
... combination of performance and rapid, small ... swinging bucket rotor. DiscoveryTMM120 SE processes ... 8.3 ml, with a small floor ... operation, rotor imbalance detection, thermo-electric cooling, ...
Medicine Products: