1

Inpharma 1650 - 9 Aug 2008 ■ New Drug Application for rivaroxaban submitted to US FDA. Johnson & Johnson Pharmaceutical Research & Development has announced that it has applied for regulatory approval for rivaroxaban, its investigational, oral, once-daily anticoagulant for the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery. Johnson & Johnson Pharmaceutical Research & Development LLC. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application to FDA for Rivaroxaban. Media Release : 30 Jul 2008. Available from: URL: http://www.jnjpharmarnd.com 809091534 1 Inpharma 9 Aug 2008 No. 1650 1173-8324/10/1650-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

New Drug Application for rivaroxaban submitted to US FDA

Download PDF Report

View
213
Download
1

Embed Size (px)

Citation preview

Page 1: New Drug Application for rivaroxaban submitted to US FDA

Inpharma 1650 - 9 Aug 2008

■ New Drug Application for rivaroxaban submittedto US FDA. Johnson & Johnson PharmaceuticalResearch & Development has announced that it hasapplied for regulatory approval for rivaroxaban, itsinvestigational, oral, once-daily anticoagulant for theprevention of deep vein thrombosis and pulmonaryembolism in patients undergoing hip or kneereplacement surgery.Johnson & Johnson Pharmaceutical Research & Development LLC. Johnson &Johnson Pharmaceutical Research & Development, L.L.C. Submits New DrugApplication to FDA for Rivaroxaban. Media Release : 30 Jul 2008. Availablefrom: URL: http://www.jnjpharmarnd.com 809091534

1

Inpharma 9 Aug 2008 No. 16501173-8324/10/1650-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Rivaroxaban for treating pulmonary embolism and preventing

Rivaroxaban for treating pulmonary embolism and preventing

Documents

Representativeness of the Dabigatran, Apixaban and Rivaroxaban

Representativeness of the Dabigatran, Apixaban and Rivaroxaban

Documents

Rivaroxaban: A New Oral Anticoagulant - Drug Interactions by

Rivaroxaban: A New Oral Anticoagulant - Drug Interactions by

Documents

St. James' Settlement St. James' Settlement rivaroxaban

St. James' Settlement St. James' Settlement rivaroxaban

Documents

FDA XML Data Format Design Specification DRAFT Cxml.coverpages.org/FDA-EGC-XMLDataFormat-C.pdf · FDA XML Data Format Design Specification ... The datasets are submitted with the

FDA XML Data Format Design Specification DRAFT Cxml.coverpages.org/FDA-EGC-XMLDataFormat-C.pdf · FDA XML Data Format Design Specification ... The datasets are submitted with the

Documents

Risk of Gastrointestinal Bleeding with Rivaroxaban: A Comparative

Risk of Gastrointestinal Bleeding with Rivaroxaban: A Comparative

Documents

Winter 2017 Inside Experience at the FDA Submitted … · Experience at the FDA. Submitted by ENS, Jennifer, Tsan. As a first-year pharmacy student ... , BC-ADM, NCPS

Winter 2017 Inside Experience at the FDA Submitted … · Experience at the FDA. Submitted by ENS, Jennifer, Tsan. As a first-year pharmacy student ... , BC-ADM, NCPS

Documents

Rivaroxaban versus enoxaparin: comparison of · PDF filestudy Rate of adherence ... Riv 19 89,5% Tabela 1 – Rate of adherence to anticoagulants Rivaroxaban versus enoxaparin:

Rivaroxaban versus enoxaparin: comparison of · PDF filestudy Rate of adherence ... Riv 19 89,5% Tabela 1 – Rate of adherence to anticoagulants Rivaroxaban versus enoxaparin:

Documents

Xarelto (rivaroxaban) Prescriber Guide · concomitantly receiving other medicinal products that increase rivaroxaban plasma concentrations. Duration of therapy Short duration of therapy

Xarelto (rivaroxaban) Prescriber Guide · concomitantly receiving other medicinal products that increase rivaroxaban plasma concentrations. Duration of therapy Short duration of therapy

Documents

Xarelto (rivaroxaban) Prescriber Guide - VATspacevatspace.com/static/media/pdf/Xarelto-Prescriber-Guide.pdf · Simple Protection for More Patients Xarelto® (rivaroxaban) Prescriber

Xarelto (rivaroxaban) Prescriber Guide - VATspacevatspace.com/static/media/pdf/Xarelto-Prescriber-Guide.pdf · Simple Protection for More Patients Xarelto® (rivaroxaban) Prescriber

Documents

FDA Document History Log - NCCIH · Web view2015/07/17 · Tool: FDA Document History Log Purpose: To record all documents submitted to the FDA Audience/User: Study coordinators,

FDA Document History Log - NCCIH · Web view2015/07/17 · Tool: FDA Document History Log Purpose: To record all documents submitted to the FDA Audience/User: Study coordinators,

Documents

Rivaroxaban bei nicht valvulärem Vorhofflimmern ... · WirkstoffWirkstoff AKTUELL Ausgabe 2/2013 Indikation Rivaroxaban bei nicht valvulärem Vorhofflimmern Gemäß internationalen

Rivaroxaban bei nicht valvulärem Vorhofflimmern ... · WirkstoffWirkstoff AKTUELL Ausgabe 2/2013 Indikation Rivaroxaban bei nicht valvulärem Vorhofflimmern Gemäß internationalen

Documents

DILI) nach Phenprocoumon und Rivaroxaban¼ller-Kolck_11.02.2017_10.30.pdf · Drug Induced Liver Insufficiency (DILI) nach Phenprocoumon und Rivaroxaban Fallbericht Handlungsempfehlungen

DILI) nach Phenprocoumon und Rivaroxaban¼ller-Kolck_11.02.2017_10.30.pdf · Drug Induced Liver Insufficiency (DILI) nach Phenprocoumon und Rivaroxaban Fallbericht Handlungsempfehlungen

Documents

Review Article Dabigatran, Rivaroxaban, or Apixaban versus … · 2019. 7. 31. · Dabigatran, Rivaroxaban, or Apixaban versus Warfarin in Patients with Nonvalvular Atrial Fibrillation:

Review Article Dabigatran, Rivaroxaban, or Apixaban versus … · 2019. 7. 31. · Dabigatran, Rivaroxaban, or Apixaban versus Warfarin in Patients with Nonvalvular Atrial Fibrillation:

Documents

Rivaroxaban plus aspirin versus with aspirin in patients

Rivaroxaban plus aspirin versus with aspirin in patients

Documents

Bridging the Gap: How to Transition from the NOACs to Warfarin · a) Stop rivaroxaban and start warfarin when the next dose of rivaroxaban is due b) Stop rivaroxaban and start warfarin

Bridging the Gap: How to Transition from the NOACs to Warfarin · a) Stop rivaroxaban and start warfarin when the next dose of rivaroxaban is due b) Stop rivaroxaban and start warfarin

Documents

Facile approach for the synthesis of rivaroxaban using

Facile approach for the synthesis of rivaroxaban using

Documents

Rivaroxaban in SPAF - swisscardio.ch · Rivaroxaban in SPAF: Efficacy, safety and cardio-vascular profile Hans Rickli, St.Gallen. ... • Dabigatran and apixaban: evaluated across

Documents

Orange County COVID-19 Vaccine Taskforce · 1. Phase 3 trial data submitted to FDA by Developer (Pfizer and Moderna done) 2. FDA Vaccines & Related Biological Products Advisory Committee

Orange County COVID-19 Vaccine Taskforce · 1. Phase 3 trial data submitted to FDA by Developer (Pfizer and Moderna done) 2. FDA Vaccines & Related Biological Products Advisory Committee

Documents

HOW TO REGISTER A HAND-SANITIZER WITH THE US FDA · using Structured Product Labeling (SPL) format should be submitted to FDA via FDA’s Electronic Submission Gateway or ESG. NDC

HOW TO REGISTER A HAND-SANITIZER WITH THE US FDA · using Structured Product Labeling (SPL) format should be submitted to FDA via FDA’s Electronic Submission Gateway or ESG. NDC

Documents

Case Report Rivaroxaban-Induced Nontraumatic Spinal ...downloads.hindawi.com/journals/crihem/2015/275380.pdf · Case Report Rivaroxaban-Induced Nontraumatic Spinal Subdural Hematoma:

Case Report Rivaroxaban-Induced Nontraumatic Spinal ...downloads.hindawi.com/journals/crihem/2015/275380.pdf · Case Report Rivaroxaban-Induced Nontraumatic Spinal Subdural Hematoma:

Documents

Oral Rivaroxaban for Symptomatic Venous Thromboembolism

Oral Rivaroxaban for Symptomatic Venous Thromboembolism

Documents

Xarelto (rivaroxaban) tablets label

Xarelto (rivaroxaban) tablets label

Documents

TRAITEMENT PAR LE RIVAROXABAN - Portail Vasculaire · 3.1. Rivaroxaban 10 mg 3.2. Rivaroxaban 15/20 mg 3.3. Blocs nerveux périphériques 4. Dosage du rivaroxaban 5. Inﬂ uence sur

TRAITEMENT PAR LE RIVAROXABAN - Portail Vasculaire · 3.1. Rivaroxaban 10 mg 3.2. Rivaroxaban 15/20 mg 3.3. Blocs nerveux périphériques 4. Dosage du rivaroxaban 5. Inﬂ uence sur

Documents

FDA Pregnancy and Lactation Labeling Rule · Drug Labeling & Lactation . FDA Pregnancy and Lactation Labeling Rule (PLLR) Rx drugs/biologics submitted after 6/30/15 will use the new

FDA Pregnancy and Lactation Labeling Rule · Drug Labeling & Lactation . FDA Pregnancy and Lactation Labeling Rule (PLLR) Rx drugs/biologics submitted after 6/30/15 will use the new

Documents

FDA ASKED TO SEVERELY RESTRICT USE OF MOST …FDA ASKED TO SEVERELY RESTRICT USE OF MOST COMMONLY-PRESCRIBED SLEEPING PILLS In a formal Citizen Petition submitted October 26, 2015,

FDA ASKED TO SEVERELY RESTRICT USE OF MOST …FDA ASKED TO SEVERELY RESTRICT USE OF MOST COMMONLY-PRESCRIBED SLEEPING PILLS In a formal Citizen Petition submitted October 26, 2015,

Documents

Effect of Co-Administration of Rivaroxaban and Clopidogrel

Effect of Co-Administration of Rivaroxaban and Clopidogrel

Documents

Measuring concentrations of Rivaroxaban, Apixaban ... · PDF fileMeasuring concentrations of Rivaroxaban, Apixaban, Edoxaban Methods and Challenges Steve Kitchen Clinical Scientist

Measuring concentrations of Rivaroxaban, Apixaban ... · PDF fileMeasuring concentrations of Rivaroxaban, Apixaban, Edoxaban Methods and Challenges Steve Kitchen Clinical Scientist

Documents

Thromboprophylaxie après arthroplastie de hanche : rivaroxaban versus enoxaparine

Thromboprophylaxie après arthroplastie de hanche : rivaroxaban versus enoxaparine

Documents

Title Rivaroxaban Versus Warfarin in Nonvalvular Atrial Fibrillation Clinical Trial Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with

Title Rivaroxaban Versus Warfarin in Nonvalvular Atrial Fibrillation Clinical Trial Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with

Documents