login
Password reminder
Cardiovascular News
Contact the editor Visit Cardiovascular News Twitter feed Visit Cardiovascular News Facebook page
 

Janssen withdraws supplemental new drug application for rivaroxaban


Tuesday, 10 Jul 2012 14:31

Janssen R&D has announced it is withdrawing the supplemental new drug application (sNDA) to the FDA for the use of rivaroxaban (Xarelto, Bayer/Janssen) to reduce the risk of stent thrombosis in patients with acute coronary syndrome (ACS).


The company is withdrawing this sNDA because it is contingent on a separate sNDA, for rivaroxaban to reduce the risk of secondary cardiovascular events in patients with ACS, which Janssen R&D received a complete response letter from the FDA on 21 June 2012. Data from the ATLAS ACS 2 TIMI 51 trial support both sNDAs.

“We remain confident in the overall study results from the ATLAS ACS 2 TIMI 51 trial, including the observed reduction in stent thrombosis that formed the basis for this separate sNDA,” said Burton. “Our top priority is to work with FDA on our original sNDA for ACS and submit our reply to the complete response letter as soon as possible. We plan to resubmit the sNDA for stent thrombosis at the same time.”




Add New Comment

Most popular


FDA proposes ban on most powdered medical gloves
Tuesday, 22 Mar 2016
The US Food and Drug Administration has announced a proposal to ban most powdered gloves in the USA. While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness ... FDA proposes ban on most powdered medical gloves

Tuesday, 01 Mar 2016
The course, designed to provide training to interventionalists on the transradial approach, was held in Merit’s new state-of-the-art training facility in its European headquarters in Maastricht, the N... First of Merit’s 2016 European ThinkRadial education courses held in Maastricht

Abbott Vascular recalls MitraClip clip delivery system
Wednesday, 16 Mar 2016
Abbott Vascular has recalled the MitraClip clip delivery system, following reports of issues with the delivery system deployment process. Abbott Vascular recalls MitraClip clip delivery system

Features


The role of sutureless and rapid-deployment valves
Tuesday, 05 Apr 2016
Antonio Miceli explores the data for sutureless and rapid-deployment surgical valves for the management of patients with severe aortic stenosis. He also reviews the place of these new devices ... The role of sutureless and rapid-deployment valves

The SCOUT study: Transcatheter tricuspid repair
Friday, 18 Mar 2016
Rebecca Hahn is the principal investigator of the SCOUT trial, which is evaluating the use of Mitralign’s transcatheter tricuspid repair system for the management of tricuspid regurgitation. She ... The SCOUT study: Transcatheter tricuspid repair

Profiles


Alexandra Lansky
Monday, 07 Mar 2016
Alexandra Lansky (Director, Heart and Vascular Clinical Research Program, Yale University School of ... Alexandra Lansky

Corrado Tamburino
Tuesday, 20 Oct 2015
Corrado Tamburino (full professor of Cardiology, Ferrarotto & Policlinico Hospitals, University of C... Corrado Tamburino

Cardiac Rhythm News Vascular News Cardiovascular News Interventional News Spinal News NeuroNews
BIBA Medical BIBA MedTech Insights CX Symposium ilegx
Password Reminder

BIBA Medical, 526 Fulham Road, Fulham, London, SW6 5NR.
TEL: +44 (0)20 7736 8788 FAX: +44 (0)20 7736 8283 EMAIL: 
info@bibamedical.com
© BIBA Medical Ltd is a company registered in England and Wales with company number 2944429.
VAT registration number 730 6811 50.
Site Map | Terms and Conditions