Nonvalvular Atrial Fibrillation
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-12-15FDA Approved: DABIGATRAN ETEXILATE — Original Application (Apotex Corp.)
FDA approved Apotex Corp.'s original application for dabigatran etexilate as a generic anticoagulant. The generic will have the same indicat…
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FDA approval · 2023-10-18FDA Approved: SAVAYSA — Supplemental Application (Daiichi Sankyo Inc.)
FDA approves a supplemental application for SAVAYSA (edoxaban tosylate) from Daiichi Sankyo, resulting in an update to the drug’s labeling.
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CLINICAL_TRIALS trial_result · 2022-07-27Clinical Trial Update: AntiCoagulants and COGnition [Phase 4]
Phase 4 clinical trial update related to anticoagulants and cognition in nonvalvular atrial fibrillation.
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FDA approval · 2021-12-20FDA Approved: XARELTO — Original Application (Janssen Pharmaceuticals, Inc.)
This FDA record documents the original approval of XARELTO (rivaroxaban) under NDA 215859, establishing its initial indication as an anticoa…
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FDA approval · 2021-06-21FDA Approved: PRADAXA — Original Application (Boehringer Ingelheim Pharmaceuticals, Inc.)
FDA approved the original application for Pradaxa (dabigatran etexilate) from Boehringer Ingelheim, marking the initial NDA approval for thi…
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FDA approval · 2020-05-06FDA Approved: DABIGATRAN ETEXILATE — Original Application (XLCare Pharmaceuticals, Inc.)
FDA approved the original application for a generic dabigatran etexilate (ANDA 207961) from XLCare Pharmaceuticals, confirming the generic’s…
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FDA approval · 2020-04-21FDA Approved: SAVAYSA — Supplemental Application (Daiichi Sankyo Inc.)
FDA approved a supplemental application for SAVAYSA (edoxaban tosylate) submitted by Daiichi Sankyo Inc., likely updating labeling and/or in…
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FDA approval · 2020-03-11FDA Approved: DABIGATRAN ETEXILATE — Original Application (Major Pharmaceuticals)
FDA approved the original application for dabigatran etexilate from Major Pharmaceuticals, approving a generic version of the anticoagulant …
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CLINICAL_TRIALS trial_result · 2018-06-13Clinical Trial Update: Safety and Effectiveness of Low Dose Edoxaban in Patients With NVAF
This clinical trial update assesses the safety and effectiveness of low-dose edoxaban in patients with nonvalvular atrial fibrillation. The …
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CLINICAL_TRIALS safety_alert · 2017-10-31Clinical Trial Update: Eliquis Regulatory Post Marketing Surveillance
Regulatory post-marketing safety surveillance update for Eliquis (apixaban) in patients with nonvalvular atrial fibrillation.
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FDA approval · 2017-09-29FDA Approved: SAVAYSA — Supplemental Application (Daiichi Sankyo Inc.)
FDA approved a supplemental application for SAVAYSA (edoxaban tosylate) by Daiichi Sankyo Inc., resulting in updated labeling.
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CLINICAL_TRIALS research · 2016-10-20Clinical Trial Update: Cerebral Microbleeds During NOACs or Warfarin Therapy in NVAF Patients With Acute Ischemic Stroke (CMB-NOW)
Clinical trial update for the CMB-NOW study. It investigates cerebral microbleeds during NOAC versus warfarin therapy in patients with nonva…
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FDA approval · 2016-09-15FDA Approved: SAVAYSA — Supplemental Application (Daiichi Sankyo Inc.)
The FDA approved a supplemental application for SAVAYSA (edoxaban tosylate) from Daiichi Sankyo Inc., expanding the drug's regulatory status…
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CLINICAL_TRIALS trial_result · 2016-05-18Clinical Trial Update: A Nationwide Registry Study of Patients With Nonvalvular Atrial Fibrillation Initiating Oral Anticoagulation Therapies In The Early Period Following Apixaban Marketing In Denmark
A nationwide Danish registry study evaluated initiation of oral anticoagulation therapies in the early period after apixaban marketing in pa…
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FDA approval · 2016-04-25FDA Approved: SAVAYSA — Supplemental Application (Daiichi Sankyo Inc.)
The FDA approved a supplemental application for SAVAYSA (edoxaban tosylate) submitted by Daiichi Sankyo to modify the label, reflecting upda…
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CLINICAL_TRIALS trial_result · 2016-04-07Clinical Trial Update: Evaluation of Hospital Readmissions Among Hospitalized Non-valvular Atrial Fibrillation (NVAF) Patients in the US
This update documents a completed clinical trial that evaluated hospital readmission rates among patients hospitalized with nonvalvular atri…
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FDA approval · 2015-09-10FDA Approved: PRADAXA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals Inc.)
The FDA approved a supplemental application for Pradaxa (dabigatran etexilate mesylate) submitted by Boehringer Ingelheim Pharmaceuticals, I…
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FDA approval · 2015-01-15FDA Approved: PRADAXA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals Inc.)
The FDA approved a supplemental application for Pradaxa (dabigatran etexilate mesylate) submitted by Boehringer Ingelheim Pharmaceuticals In…
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FDA approval · 2012-12-19FDA Approved: PRADAXA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals Inc.)
FDA approved a supplemental application for Pradaxa (dabigatran etexilate mesylate) from Boehringer Ingelheim Pharmaceuticals Inc., to modif…
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FDA approval · 2012-11-02FDA Approved: XARELTO — Supplemental Application (Janssen Pharmaceuticals, Inc.)
FDA approved a supplemental application for XARELTO (rivaroxaban) filed by Janssen Pharmaceuticals, Inc.
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FDA approval · 2011-11-09FDA Approved: PRADAXA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals Inc.)
FDA approved Boehringer Ingelheim Pharmaceuticals' supplemental application for Pradaxa (dabigatran etexilate mesylate).
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CLINICAL_TRIALS trial_result · 2011-09-22Clinical Trial Update: Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation [Phase 2]
Phase 2 trial results on prevention of stroke and systemic embolic events in patients with nonvalvular atrial fibrillation; status completed…
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CLINICAL_TRIALS trial_result · 2011-07-28Clinical Trial Update: Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA) [Phase 2]
A Phase 2 trial update for persistent or permanent non-valvular atrial fibrillation in patients not taking vitamin K antagonists; the study …
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FDA approval · 2011-07-01FDA Approved: XARELTO — Original Application (Janssen Pharmaceuticals, Inc.)
The FDA documents the approval of the original application for Xarelto (rivaroxaban) from Janssen Pharmaceuticals.
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FDA approval · 2010-10-19FDA Approved: PRADAXA — Original Application (Boehringer Ingelheim Pharmaceuticals Inc.)
The FDA approved Pradaxa (dabigatran etexilate mesylate) under an original NDA from Boehringer Ingelheim Pharmaceuticals Inc.