Navigation Links
Janssen Research & Development Submits XARELTO® (rivaroxaban) to U.S. FDA for the Treatment and Prevention of Recurrent Venous Thromboembolism
Date:5/2/2012

RARITAN, N.J., May 2, 2012 /PRNewswire/ -- Janssen Research & Development, LLC, (Janssen), announced today that it has submitted supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of XARELTO® (rivaroxaban), an oral anticoagulant, to treat patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) and prevention of recurrent venous thromboembolism (VTE).

These submissions are supported by data from the global EINSTEIN program, which included two Phase 3 studies that evaluated the safety and efficacy of rivaroxaban in the treatment of patients with acute symptomatic DVT or PE and the prevention of recurrent, symptomatic VTE in these patients. The third Phase 3 study evaluated the safety and efficacy of rivaroxaban in the long-term prevention of recurrent symptomatic VTE. In total, these Phase 3 studies included more than 9,400 patients.

DVT is a condition in which blood clots form in one of the large, deep veins, usually in the legs. PE is a serious condition that most commonly occurs when part or all of a DVT dislodges and travels to the heart, where it can partially or completely block a branch of the pulmonary artery. When PE occurs with large clots, multiple clots, or when the patient already has pre-existing heart or lung disease, the event may be fatal.  VTE is the collective term for both DVT and PE. Each year an estimated 900,000 Americans experience an episode of VTE, resulting in an estimated 300,000 annual deaths.

About the EINSTEIN Program
The EINSTEIN program included three Phase 3 studies. The EINSTEIN-PE study was an open-label, randomized, non-inferiority trial. The trial compared oral rivaroxaban – 15 mg twice daily for three weeks, followed by 20 mg once daily – with the current standard of care of enoxaparin followed by a Vitamin K Antagonist (VKA) in patients with acute symptomatic PE with or without
'/>"/>

SOURCE Janssen Research & Development, LLC
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Janssen Research & Development, LLC Opens JANSSEN LABS at San Diego
2. Janssen Research & Development Submits Application to U.S. FDA for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome
3. Record Breaking $327 Million Verdict Upheld in Janssen Case and Request for New Trial Denied
4. Dr. Paul Janssen Award for Biomedical Research Issues Call for Nominations
5. Pharmacyclics Forms Pact to Develop and Commercialize PCI-32765 for Hematologic Cancers with Janssen Biotech, Inc.
6. Janssen Pharmaceuticals, Inc. Launches Online Tools on PrescribeResponsibly.com
7. Janssen Pharmaceuticals, Inc. Announces Definitive Agreement to Divest Ortho Dermatologics Division
8. Dr. Napoleone Ferrara Wins 2011 Dr. Paul Janssen Award for Biomedical Research
9. Janssen Products, LP Modifies Prescribing Information for PROCRIT® (Epoetin alfa) in Chronic Kidney Disease
10. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Voluntarily Recalls One Lot of RISPERDAL® Tablets and One Lot of Risperidone Tablets
11. Record Breaking $327 Million Verdict Announced in Janssen Case
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/29/2015)... and MENLO PARK, Calif. , ... Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), ... proven cancer therapies in new orphan drug indications, ... Association of Cancer Research (AACR) Advances in Brain ... its lead product candidate VAL-083 (dianhydrogalactitol) ...
(Date:5/29/2015)... MALVERN, Pa. , May 29, 2015 /PRNewswire-USNewswire/ ... major focus of the Association for the Advancement ... 1995. With support from AAWC,s corporate ... Educational Portal on the AAWC website ... on a wound care pathway with links to ...
(Date:5/28/2015)... , May 28, 2015 ... has announced the addition of Jain PharmaBiotech,s ... Companies"  to their offering.  ... (RNAi) or gene silencing involves the use ... the cell, this material is processed into ...
Breaking Medicine Technology:DelMar Pharmaceuticals Presents Additional Data on the Potential of VAL-083 in the Treatment of Temozolomide-Resistant Glioblastoma Multiforme 2DelMar Pharmaceuticals Presents Additional Data on the Potential of VAL-083 in the Treatment of Temozolomide-Resistant Glioblastoma Multiforme 3DelMar Pharmaceuticals Presents Additional Data on the Potential of VAL-083 in the Treatment of Temozolomide-Resistant Glioblastoma Multiforme 4DelMar Pharmaceuticals Presents Additional Data on the Potential of VAL-083 in the Treatment of Temozolomide-Resistant Glioblastoma Multiforme 5The Association for the Advancement of Wound Care Educates the Public 2Global RNAi Market Report 2015-2024 - Technologies, Markets and Companies 2Global RNAi Market Report 2015-2024 - Technologies, Markets and Companies 3
... Corporation, a global leader in automated external defibrillators ( ... will supply hundreds of Powerheart® G3 AEDs for "Defib ... from sudden cardiac arrest (SCA) among athletes, officials and ... (Logo:  http://photos.prnewswire.com/prnh/20080306/AQTH510LOGO ) The campaign was ...
...  JDRF announced today its support of a pioneering diabetes ... for type 1 diabetes (T1D) and other forms of ... packages immature cells made from human embryonic stem cells ... producing cells (pro-islet) including insulin-producing cells. The research is ...
Cached Medicine Technology:Australia's Sporting Clubs Select Cardiac Science AEDs 2Australia's Sporting Clubs Select Cardiac Science AEDs 3Australia's Sporting Clubs Select Cardiac Science AEDs 4JDRF to Support ViaCyte's Development of Innovative Encapsulated Beta Cell Replacement Therapy for Diabetes 2JDRF to Support ViaCyte's Development of Innovative Encapsulated Beta Cell Replacement Therapy for Diabetes 3JDRF to Support ViaCyte's Development of Innovative Encapsulated Beta Cell Replacement Therapy for Diabetes 4
(Date:5/29/2015)... May 29, 2015 As spring has ... Metro series outdoor saunas have increased in popularity as ... and work at summer cottages. While a perennial ... in summer projects a few weeks earlier than usual. ... with smaller lot sizes tend to prefer the Patio ...
(Date:5/29/2015)... 2015 The FSH Society ... science of the little-known and incurable disease, facioscapulohumeral ... the second FSHD Trial Preparedness Workshop. The Workshop, ... University of Rochester Medical Center in Rochester, New ... around the world, including representatives from industry, the ...
(Date:5/29/2015)... CA (PRWEB) May 29, 2015 For the ... (USAU) to bring the Denver youth ultimate community an opportunity ... learning and individual improvement. The mission of the USAU Nike ... boys and girls to improve, build character, and make lifelong ... for boys and girls of all skill and ability levels, ...
(Date:5/29/2015)... (PRWEB) May 29, 2015 Recently, ... on longevity in facelift surgery before the 46th National ... Vallarta, Mexico. In his presentation, Dr. Rohrich, a ... Teaching Professor of Plastic Surgery at UT Southwestern Medical ... facial rejuvenation as they relate to obtaining long term ...
(Date:5/29/2015)... DISC, a method of behavioral analysis that ... used by companies to improve hiring practices, streamline training, ... an out-of-the-box practice, has now become an integral part ... Society for Human Resource Management found that over 70% ... be an essential part of the hiring process, and ...
Breaking Medicine News(10 mins):Health News:As Summer Approaches, Finnleo Notes Increased Interest in Patio and Metro Outdoor Saunas 2Health News:International Conference Brings Together Key Stakeholders to Advance Clinical Trial Readiness for FSHD 2Health News:International Conference Brings Together Key Stakeholders to Advance Clinical Trial Readiness for FSHD 3Health News:US Sports Camps, Nike Sports Camps, and USA Ultimate Host Third Summer of Ultimate Camp in Denver 2Health News:Dr. Rod J. Rohrich Speaks on Longevity in Facelifts and Facial Rejuvenation 2Health News:Dr. Rod J. Rohrich Speaks on Longevity in Facelifts and Facial Rejuvenation 3Health News:PeopleKeys to Air a Follow-up to Their Popular DISC Trainer’s Toolbox Webinar, Featuring All-New Content and Strategies 2
... issue of Cancer Cell says that scientists have identified ... how cancer progresses.// This molecule was found to inhibit ... vivo as well as in vitro. , ,This ... inhibitors must display a broad reactivity to effectively attenuate ...
... its ultimate destination, has caught the interest of researchers ... finding will open doors for enabling better treatments for ... ,The findings also lay the foundation for many ... where new neurons are generated from stem cells in ...
... San Francisco (UCSF) they have identified a class of compounds ... called the PI-103 acts as a potent drug candidate against ... grafts the drug is found to be potent against proliferating ... ability to attack two separate steps in the series of ...
... reliever and fever reducer after a heart attack it cannot ... new study using sheep and rabbits concluded. // ... people who have suffered heart attacks, about a million people ... a medical doctor and associate professor of surgery at the ...
... about 4.1 million people in the US are infected with ... was found to be 1.6%. The Hepatitis C virus affects ... Drug users suffer from a high risk of developing the ... factor for liver transplantation. About 15,079 participants in the National ...
... Sanyo, one of the leading providers of environment ... on Monday that its proprietary electrolysed water technology ... ,In joint research with Tottori University, a national ... technology, ‘Disinfectant Element’ system and ‘Disinfectant Electrolysed Mist’ ...
Cached Medicine News:Health News:Discovery Of New Molecule Could Solve Cancer Spread Mystery 2Health News:Ultimate Destination of anti-depressant, Prozac 2Health News:PI-103 Effective against Brain Cancer 2Health News:PI-103 Effective against Brain Cancer 3Health News:Acetaminophen does not Protect Heart Muscle 2Health News:Acetaminophen does not Protect Heart Muscle 3Health News:Sanyo’s Electrolysed Water Technology Effective In Suppressing Bird Fl 2
The Riboprinter microbial characterization system provides the speed, accuracy and resolution needed to identify microorganisms and characterize them efficiently and consistently. These determination...
A versatile plate washer and/or dispenser that aspirates from the top down without immersing the aspirating tubes in the well, ensuring overflow protection. 5 programmable protocols....
... performance plus simple operation ... and efficient washing of ... performed with minimum loss ... while membrane bound labels ...
... has set a standard for ultra-fast washing ... instrument not only processes all 384 wells ... further boost wash performance. This wash procedure ... times as no transport steps to index ...
Medicine Products: