Atrial Flutter

• CLINICAL_TRIALS trial_result · 2014-04-23
  Clinical Trial Update: Sodium Channel Splicing in Heart Failure Trial

  The trial update reports the completion of a study on sodium channel splicing in heart failure and notes related conditions including atrial…

• FDA approval · 2014-03-31
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Multaq (dronedarone) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2014-03-19
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental NDA for MULTAQ (dronedarone) submitted by Sanofi-Aventis U.S. LLC.

• CLINICAL_TRIALS trial_result · 2014-02-19
  Clinical Trial Update: Pharmacogenetic Dosing of Warfarin [Phase 3]

  Phase 3 clinical trial evaluating pharmacogenetic dosing of warfarin has completed, assessing personalized dosing strategies. Sponsored by A…

• CLINICAL_TRIALS research · 2014-01-31
  Clinical Trial Update: Therapy of Atrial Flutter by Afib Ablation [NA]

  This entry reports a University of Rostock-sponsored clinical trial evaluating ablation therapy for atrial flutter in patients with atrial f…

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• FDA approval · 2014-01-30
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for MULTAQ (dronedarone) submitted by Sanofi-Aventis U.S. LLC.

• CLINICAL_TRIALS trial_result · 2013-12-23
  Clinical Trial Update: Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System [Phase 3]

  Phase 3 clinical trial update for the Cool Path Ablation System with EnSite Velocity Contact System in typical atrial flutter. The study has…

• CLINICAL_TRIALS trial_result · 2013-12-16
  Clinical Trial Update: Comparison of Diltiazem and Metoprolol in the Management of Acute Atrial Fibrillation or Atrial Flutter [Phase 4]

  Phase 4 trial comparing diltiazem and metoprolol for management of acute atrial fibrillation or atrial flutter; results have been completed …

• FDA approval · 2013-12-06
  FDA Approved: TIKOSYN — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Tikosyn (dofetilide) from Pfizer Laboratories Div Pfizer Inc.

• CLINICAL_TRIALS trial_result · 2013-12-06
  Clinical Trial Update: Strategy of Early Detection and Active Management of Supraventricular Arrhythmia With Telecardiology (SETAM) [NA]

  The SETAM study, sponsored by Biotronik France, completed evaluating early detection and active management of supraventricular arrhythmias u…

• CLINICAL_TRIALS research · 2013-09-27
  Clinical Trial Update: A Retrospective Analysis of the Use of ACE-inhibitors and Angiotensin Receptor Blockers

  A retrospective analysis examines how ACE inhibitors and ARBs are used in patients with atrial fibrillation or atrial flutter. The study sta…

• CLINICAL_TRIALS trial_result · 2013-09-27
  Clinical Trial Update: Markers of Oxidative Stress Present in Blood in Patients With Atrial Fibrillation

  A completed clinical trial update investigating markers of oxidative stress in the blood of patients with atrial fibrillation.

• CLINICAL_TRIALS research · 2013-09-27
  Clinical Trial Update: Markers of Oxidative Stress Present in Left Atrial Appendage Tissue in Patients With Atrial Fibrillation

  A terminated clinical trial investigated markers of oxidative stress in left atrial appendage tissue from patients with atrial fibrillation …

• CLINICAL_TRIALS trial_result · 2013-06-18
  Clinical Trial Update: Catheter Ablation as the First Line Therapy for Typical Atrial Flutter [Phase 4]

  A Phase 4 trial evaluating catheter ablation as first-line therapy for typical atrial flutter has been terminated.

• FDA approval · 2013-05-31
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for amiodarone hydrochloride submitted by Chartwell RX, LLC. This marks an approval of a supplement …

• FDA label_change · 2013-05-21
  FDA Approved: LANOXIN — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approved a supplemental label change for Lanoxin (digoxin) submitted by Advanz Pharma (US) Corp.

• FDA approval · 2013-05-21
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Gland Pharma Limited)

  The FDA approved a supplemental application for amiodarone hydrochloride from Gland Pharma Limited, enabling its generic use.

• FDA approval · 2013-05-16
  FDA Approved: LANOXIN — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for LANOXIN (digoxin) submitted by Covis Pharma US, Inc.

• CLINICAL_TRIALS trial_result · 2013-04-29
  Clinical Trial Update: Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation [Phase 3]

  Phase 3 trial update for apixaban in preventing stroke in atrial fibrillation. The ARISTOTLE trial has completed and results were posted in …

• CLINICAL_TRIALS trial_result · 2013-04-10
  Clinical Trial Update: Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies [NA]

  The clinical trial update reports completion and posting of results for a study evaluating the Amigo catheter robotics system for right-side…

• FDA approval · 2013-03-27
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA posted a supplemental approval application for MULTAQ (dronedarone) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2012-12-07
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s generic diltiazem hydrochloride (ANDA 202463). The product is indicated for the management of hypertensi…

• FDA approval · 2012-11-26
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approves a supplemental application for verapamil hydrochloride from Actavis Pharma, Inc. for an already authorized product.

• FDA approval · 2012-09-07
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Multaq (dronedarone) filed by Sanofi-Aventis U.S. LLC. The approval updates the drug's labeling …

• FDA approval · 2012-08-24
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental abbreviated new drug application for diltiazem hydrochloride from Sun Pharmaceutical, a generic calcium channel …