Navigation Links
U.S. FDA Grants Priority Review for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome
Date:2/27/2012

RARITAN, N.J., Feb. 27, 2012 /PRNewswire/ -- Janssen Research & Development, LLC (JRD) announced today that the U.S. Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug Application (sNDA) filed on December 29, 2011 for XARELTO® (rivaroxaban), an oral anticoagulant, to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS).

The FDA grants Priority Review to medicines that offer advances in care or that provide a treatment where no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), FDA will complete its review within six months from the receipt of the sNDA submission, rather than the standard 10 month review cycle.

The submission was based on results from the pivotal Phase 3 ATLAS ACS 2 TIMI 51 (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome) trial that were presented in November 2011 at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine (10.1056/NEJMoa1112277).

ACS is a complication of coronary heart disease, which is the leading cause of death in the U.S. and one of the most prevalent non-communicable diseases in the world. ACS occurs when a blood clot blocks a coronary artery, reducing blood supply to the heart. This disruption of blood flow can cause a heart attack, or unstable angina, a condition signifying that a heart attack may soon occur. Each year, an estimated 1.2 million patients in the U.S. are discharged from the hospital with a primary or secondary diagnosis of ACS.

About XARELTO® (rivaroxaban)

XARELTO® belongs to a group of medicine
'/>"/>

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. FDA Grants Petition for Removal From Import Alert
2. FDA Grants Orphan Drug Designation to Ikaria® For Use of Inhaled Nitric Oxide in Pulmonary Arterial Hypertension
3. FDA Grants 510(k) Clearance to Curos® Disinfecting Port Protector
4. Optimer Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
5. US Patent Office Grants COPAN Invention of Flocked Swabs
6. The European Commission Grants Marketing Authorization for DIFICLIR™ (fidaxomicin) Tablets for Treatment of Clostridium difficile Infections
7. Watson Confirms Court Grants Preliminary Injunction Preventing Launch of Generic LOVENOX®
8. FDA Awards NIPTE Potential $35 Million in Grants to Reform Drug Manufacturing Process
9. Optimer Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
10. Pevion Grants CSL Option Right to its Therapeutic Candida Vaccine
11. Muscular Dystrophy Association Awards $13.7 Million for 40 New Research Grants
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2015)... , May 27, 2015 ... announced the addition of the  "US Cancer ... their offering.       (Logo: http://photos.prnewswire.com/prnh/20130307/600769) ... into to two broad categories of prophylactic ... cancer vaccines belong to both of these ...
(Date:5/27/2015)... 26, 2015 Research and Markets( http://www.researchandmarkets.com/research/ljsxt8/asia_pacific ) has ... Ray Devices Market - Growth, Trends And Forecasts (2014 - ... Asia Pacific market for Portable X-Ray ... 2014 to 2020 X-Ray is a form of ... the body, especially bones. The need of point of care ...
(Date:5/27/2015)... Research and Markets( http://www.researchandmarkets.com/research/nt9zlx/asia_pacific ) has announced ... - Growth, Trends And Forecasts (2014 - 2019)" ... a detailed type of imaging that customs a low-dose ... a mammogram, is used to support in the early ... x-ray (radiograph) is a noninvasive medical test that helps ...
Breaking Medicine Technology:US Cancer Vaccine Market Outlook 2020 2US Cancer Vaccine Market Outlook 2020 3Asia Pacific Portable X Ray Devices Market 2015 - Trends And Forecasts to 2019 2Asia Pacific Mammography Market Trends and Forecasts 2015-2019 2
(Date:5/27/2015)... (PRWEB) May 27, 2015 Genius Monkey ... their advanced programmatic marketing technology, they have boosted sales ... support on a regional level for seven Utah-based dealers. ... was through television and radio media. In 2014 the ... the help of Genius Monkey , shifted their ...
(Date:5/27/2015)... With InnerVoice Communication App you will ... is not only heard but seen -- by a photograph ... image. This award-winning and affordable app takes full advantage of ... InnerVoice Sender app in conjunction with InnerVoice Communication ... remotely for no additional cost. , InnerVoice Sender ...
(Date:5/27/2015)... 27, 2015 With a prevalently high ... conducted during the "ACA - Controlling the Chaos" webinar ... are currently in the process of researching ACA ... confidently prepared for the reporting mandates. , According to ... webinar, those who are currently vetting ACA reporting solutions ...
(Date:5/27/2015)... http://www.smarterskindermatology.com , is taking skin care customization to a ... for patients to find skin care products that work specifically ... a cosmetic dermatologist based in New York and is the ... DNA test uses 16 genetic markers to evaluate the following ... Firmness and elasticity , 2. Glycation , 3. Sun damage ...
(Date:5/27/2015)... 27, 2015 Decorview , a ... is offering free design advice to homeowners looking to ... , “Light pollution caused by streetlights, outdoor signs, full ... night’s sleep, said Kim Rush, VP of sales and ... across North America with recently installed LED streetlights– the ...
Breaking Medicine News(10 mins):Health News:Genius Monkey Boosts Utah Honda Dealers Website Traffic 142% 2Health News:Newly Released: InnerVoice Sender App Ups the Ante in Communication Technology for Autism with Remote Prompting 2Health News:Newly Released: InnerVoice Sender App Ups the Ante in Communication Technology for Autism with Remote Prompting 3Health News:Newly Released: InnerVoice Sender App Ups the Ante in Communication Technology for Autism with Remote Prompting 4Health News:Employers are On Track for ACA Reporting According to Businessolver Poll 2Health News:SmarterSkin Dermatology is Now Offering Skin DNA Analysis 2Health News:Decorview Helps Homeowners Combat Light Pollution 2
... students to surgeons, anyone who has pulled an all-nighter knows ... trouble focusing, a fuzzy memory and other cognitive impairments. ... brain and the neurochemical basis for sleep deprivation,s effects on ... Penn,s School of Arts and Sciences and director of the ...
... By Jenifer Goodwin HealthDay Reporter , TUESDAY, ... Drug Administration advisory committees plan to meet Tuesday and ... instructions on the labels of medicines containing acetaminophen need ... of 2 against possible liver failure and even death. ...
... By Amanda Gardner HealthDay Reporter , TUESDAY, ... 30 percent of their hospital emergency rooms in the past ... than 35 percent, new research shows. And the closures ... who are poor, publicly insured or uninsured -- people without ...
... 17, 2011 -- In New York City, the prevalence ... anywhere from 3% to 19%, and children growing up ... fold differences in risk for having asthma. In ... localized differences, researchers at Columbia University,s Mailman School of ...
... A study conducted at the University of Arizona College ... clinical decision support software systems the computer programs ... medication problems correctly identified potentially dangerous drug-drug interactions. ... Arizona. Members of the research team tested the pharmacy ...
... News) -- A gene variation that causes faulty cholesterol regulation ... and may be a reason why some women can,t get ... at more than 200 infertile women who were undergoing in ... of the scavenger receptor class B type 1 (SCARB1) gene. ...
Cached Medicine News:Health News:Penn researchers identify the roots of memory impairment resulting from sleep deprivation 2Health News:Penn researchers identify the roots of memory impairment resulting from sleep deprivation 3Health News:FDA Panels to Weigh Dosing Labels for Kids' OTC Fever Relievers 2Health News:FDA Panels to Weigh Dosing Labels for Kids' OTC Fever Relievers 3Health News:FDA Panels to Weigh Dosing Labels for Kids' OTC Fever Relievers 4Health News:Almost 30% of Urban ERs Closed During Past Two Decades: Study 2Health News:Almost 30% of Urban ERs Closed During Past Two Decades: Study 3Health News:Cockroach allergens in homes associated with prevalence of childhood asthma in some neighborhoods 2Health News:Gene Variation May Explain Some Female Infertility Cases 2
MiniCycler thermal cycler with Hot Bonnet heated lid, holds 16x0.5ml tubes...
Dual-bay Dyad thermal cycler chassis, does not include the Alpha units (requires 2)...
... Sprint with 24-well x 0.2ml sub-ambient block ... tube thermistor) Heating rates: up to 3C/second; ... 4-99C; Excellent uniformity: better than 0.5C within ... use programming: directory program storage of up ...
... an inexpensive personal or mini thermal cycler, and ... with a small footprint, it can be easily ... desk. , The Gene Cycler thermal cycler meets ... access to a large laboratory thermal cycler, or ...
Medicine Products: