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:11/21/2014)... GABLES, Fla. , Nov. 20, 2014   ... to become the first U.S. commercial producer of Molybdenum-99 ... a contract with INVAP to design its ... Fla. Mo-99 is the parent isotope of ... medicine procedures worldwide. In 2012, Congress passed legislation making ...
(Date:11/21/2014)... , Nov. 21, 2014  Lexicon Pharmaceuticals, Inc. (Nasdaq: ... its previously announced underwritten public offering of $50,000,000 of ... shelf registration statement. The offering will consist of 49,751,244 ... of $1.005 per share.  Lexicon has also granted the ... additional shares of common stock.  All of the shares ...
(Date:11/18/2014)... 18, 2014 Respiratory Motion and IMI Co ... device and services providers in Japan ... Motion,s innovative respiratory depression monitor, the ExSpiron™. As part ... working together to connect the clinical community in promoting ... of bringing innovative medical devices and new technology to ...
Breaking Medicine Technology:Coqui RadioPharmaceuticals Inks Deal With INVAP 2Lexicon Announces Pricing Of Common Stock Offering 2Lexicon Announces Pricing Of Common Stock Offering 3Prominent Japanese Med Device Provider to be Respiratory Motion's Exclusive Partner for World's #2 Medical Market 2Prominent Japanese Med Device Provider to be Respiratory Motion's Exclusive Partner for World's #2 Medical Market 3Prominent Japanese Med Device Provider to be Respiratory Motion's Exclusive Partner for World's #2 Medical Market 4
... 14 Merrimack Pharmaceuticals,Inc. today announced that enrollment ... 100 patients that evaluates the safety and efficacy ... rheumatoid arthritis (RA). MM-093 is a,recombinant version of ... Phase 2 study is,being conducted at 20 centers ...
... Inc.,(Amex: ILE ) announced today the completion ... II/III Study IT-A-008 investigating the Isolagen,Therapy(TM) for the ... will be administered at seven clinical sites across ... Isolagen Therapy could hold great promise for the,treatment ...
Cached Medicine Technology:Merrimack Pharmaceuticals Completes Enrollment in a Phase 2 Study of MM-093 in Patients with Rheumatoid Arthritis 2Isolagen, Inc. Completes Enrollment in Isolagen Therapy(TM) Phase II/III Acne Scar Study 2Isolagen, Inc. Completes Enrollment in Isolagen Therapy(TM) Phase II/III Acne Scar Study 3
(Date:11/23/2014)... November 23, 2014 SWAccessControl.com's high quality ... market. Recently, the company has announced its new collection ... offer on these high quality power suppliers. All the ... off. The special offer lasts until Dec. 20, 2014. ... of them have been supporting it for a long ...
(Date:11/23/2014)... “BlackVue” was featured on NewsWatch as part of ... latest and coolest technology products available to consumers. Mallory ... the product review and shared with viewers how their ... car camera industry. , The need for in-car video ... find the one that’s right per consumer, especially considering ...
(Date:11/23/2014)... 2014 BambooFlooringChina.com , the world’s leader ... strand woven bamboo flooring collection. Now, the business is ... company’s CEO, the promotion is valid until Dec. 20, 2014. ... a smooth and dust-free surface, which makes it very easy ... industry, the company wants to make its website the best ...
(Date:11/22/2014)... (PRWEB) November 23, 2014 Cancer researchers ... a connection between intercellular communication tunnels and the growth ... the full story on the Surviving Mesothelioma website. ... and the University of Minnesota have just released their ... information and materials between cells. They found that ...
(Date:11/22/2014)... Recently, Locks-Magnetic.com , one of the successful ... mag locks for glass doors online. In addition, the ... fresh products. Customers can get more information on its ... in excellent performance. Customers who want to buy this ... possible. They also can enjoy the one-stop shopping ...
Breaking Medicine News(10 mins):Health News:Cheap Access Control Power Supplies Online Now at SWAccessControl.com, Special Offer Until Dec. 20, 2014 2Health News:A Leader in Front and Rear Facing In-Car Cameras was Featured on NewsWatch Television on October 30, 2014 2Health News:Click Strand Woven Bamboo Flooring From Famous Bamboo Flooring Company BambooFlooringChina.com 2Health News:Study Links Cellular ‘Tunnels’ to Mesothelioma Proliferation, According to Surviving Mesothelioma 2Health News:Discounted Mag Locks for Glass Doors Revealed by Locks-Magnetic.com 2
... HealthDay Reporter , THURSDAY, July 29 (HealthDay News) -- ... other when it comes to what patients believe about their ... and what,s the best way to manage the problem, new ... a lack of communication, researchers said. Patients who were "active ...
... cell that has been largely ignored by cancer researchers can, ... by Howard Hughes Medical Institute (HHMI) scientists and their colleagues. ... at the University of California, Los Angeles (UCLA) found that ... the prostate gland. Their studies, which were unveiled in the ...
... Neuroscientists have long wondered how individual connections between brain cells ... in the prestigious science journal Neuron , a new ... of Medicine at Tel Aviv University describes what makes some ... natural molecule that occurs in the brain, which could be ...
... likely the cause of the feminization of fish say researchers ... their study in the journal Environmental Toxicology and Chemistry ... huge geographical area we covered. We found that chemicals ... harm fish were present along approximately 600 km of river," ...
... HealthDay Reporter , THURSDAY, July 29 (HealthDay News) -- Will ... class? Will panels decide what care very sick, older people ... A new Harris Interactive/HealthDay poll shows confusion still reigns when ... President Barack Obama back in March. More than 2,100 ...
... release is available in Spanish . , Mushrooms ... role in keeping the immune system healthy. Now, Agricultural Research ... showing that white button mushrooms enhanced the activity of critical ... States, white button mushrooms represent 90 percent of the total ...
Cached Medicine News:Health News:Doctors, Patients Rarely on Same Page 2Health News:Doctors, Patients Rarely on Same Page 3Health News:A new ground zero for prostate cancer 2Health News:A new ground zero for prostate cancer 3Health News:Memory's master switch 2Health News:Memory's master switch 3Health News:Gender-bending fish on the rise in southern Alberta 2Health News:Americans Still Confused About Health Reform 2Health News:Americans Still Confused About Health Reform 3Health News:Americans Still Confused About Health Reform 4
Omniseal TD mat. Reusable rubber mat for sealing PCR plates. 5 pk....
Inquire...
... heat-resistant, aluminum foil film designed for the ... minimizes evaportaion and vapor loss during thermal ... devices or mats. Its proprietary adhesive ... Compared to other aluminum foils, AlumaSeal ...
Microseal 'F' foil, seals plates for cold storage (or cycling >25l), disposable, pkg of 100...
Medicine Products: