Ventricular Arrhythmias

• FDA approval · 2021-04-21
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approves Zydus Lifesciences Limited's original application for propafenone hydrochloride (generic). The approval covers the treatment of…

• FDA approval · 2021-02-04
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (AiPing Pharmaceutical, Inc.)

  FDA approved AiPing Pharmaceutical, Inc.'s supplemental application for Sotalol Hydrochloride.

• FDA approval · 2021-01-27
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Sotalol Hydrochloride from Apotex Corp., approving changes to this generic product.

• CLINICAL_TRIALS trial_result · 2020-09-04
  Clinical Trial Update: Antiarrhythmic Effects of Spironolactone in Patients With ICDs [Phase 4]

  Phase 4 trial update evaluating antiarrhythmic effects of spironolactone in patients with implantable cardioverter-defibrillators; results p…

• FDA approval · 2020-07-22
  FDA Approved: MEXILETINE HYDROCHLORIDE — Original Application (Chartwell RX, LLC)

  FDA approved an original abbreviated new drug application for mexiletine hydrochloride (generic) to Chartwell RX, LLC.

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• CLINICAL_TRIALS trial_result · 2019-02-04
  Clinical Trial Update: Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT)

  A completed clinical trial update evaluating risk stratification and benefits of Cardiac Resynchronization Therapy (CRT) in patients with he…

• FDA approval · 2018-11-02
  FDA Approved: SOTALOL HYDROCHLORIDE AF — Original Application (UNICHEM PHARMACEUTICALS (USA), INC.)

  FDA approved Sotalol Hydrochloride AF tablets from Unichem Pharmaceuticals (USA), Inc. as an original application generic product for treati…

• CLINICAL_TRIALS trial_result · 2018-10-24
  Clinical Trial Update: PROSPECTIVE ANALYSIS BETWEEN AMIODARONE Versus LIDOCAINE IN SVT [Phase 4]

  Prospective Phase 4 trial comparing amiodarone versus lidocaine in ventricular arrhythmias.

• CLINICAL_TRIALS trial_result · 2018-06-19
  Clinical Trial Update: Acute Study to Collect Electrical Signals From the Heart Using a Special Lead [NA]

  A completed Medtronic clinical trial evaluated a special heart lead intended to collect electrical signals for patients with tachycardia and…

• FDA approval · 2017-09-08
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's Propafenone hydrochloride generic product under an Original Application (ANDA).

• CLINICAL_TRIALS trial_result · 2017-02-17
  Clinical Trial Update: Multimodal Image Processing Software to Guide Cardiac Ablation Therapy

  A completed clinical trial evaluated a multimodal image processing software designed to guide cardiac ablation therapy. The study addressed …

• CLINICAL_TRIALS trial_result · 2017-02-13
  Clinical Trial Update: Acute Defibrillation Study [NA]

  Terminated clinical trial sponsored by Medtronic Cardiac Rhythm and Heart Failure evaluating acute defibrillation in ventricular arrhythmias…

• CLINICAL_TRIALS trial_result · 2016-12-02
  Clinical Trial Update: Acute Subcutaneous Defibrillation

  This clinical trial update reports the completed results of a trial evaluating acute subcutaneous defibrillation for ventricular arrhythmias…

• FDA approval · 2016-10-21
  FDA Approved: SOTALOL — Original Application (UNICHEM PHARMACEUTICALS (USA), INC.)

  FDA approved an original ANDA for sotalol hydrochloride (Sotalol) from Unichem Pharmaceuticals (USA), Inc., enabling generic access to this …

• FDA approval · 2016-05-10
  FDA Approved: BETAPACE — Supplemental Application (Legacy Pharma USA, Inc.)

  The FDA approved a supplemental application for BETAPACE (sotalol hydrochloride) filed by Legacy Pharma USA, Inc.

• FDA approval · 2015-12-21
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approves a supplemental application for Inderal LA (propranolol hydrochloride) by ANI Pharmaceuticals, Inc., granting approval for chang…

• FDA approval · 2015-07-01
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for sotalol hydrochloride from Apotex Corp., indicating approval of a generic sotalol product.

• FDA approval · 2015-04-28
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  The FDA approved a supplemental application for sotalol hydrochloride by Oxford Pharmaceuticals, LLC. Sotalol is used to treat certain heart…

• FDA approval · 2015-04-27
  FDA Approved: MEXILETINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for mexiletine hydrochloride (Teva) to update its labeling.

• FDA approval · 2014-09-04
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's supplemental application for sotalol hydrochloride (generic). This action confirms regulatory clearance related to the g…

• CLINICAL_TRIALS trial_result · 2013-09-10
  Clinical Trial Update: Psychoeducational Intervention for ICD Patients (PEACE) [NA]

  This is a completed clinical trial update for the PEACE psychoeducational program for patients with implantable cardioverter-defibrillators …

• CLINICAL_TRIALS research · 2013-07-22
  Clinical Trial Update: Study of Defibrillation Testing In Patients Undergoing Initial ICD Implantation [Phase 4]

  A Phase 4 clinical trial evaluating defibrillation testing during initial ICD implantation, with current status listed as UNKNOWN.

• CLINICAL_TRIALS trial_result · 2013-03-01
  Clinical Trial Update: Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds [NA]

  A completed clinical trial sponsored by Abbott Medical Devices evaluated the safety and efficacy of an automatic testing feature in new impl…

• CLINICAL_TRIALS research · 2012-06-26
  Clinical Trial Update: Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients [NA]

  An update on a clinical trial evaluating home-monitoring in patients with implantable cardioverter defibrillators. The current trial status …

• CLINICAL_TRIALS trial_result · 2012-02-09
  Clinical Trial Update: Effect of Ranolazine on Arrhythmias and Microvolt T- Wave Alternans (MVTWA) Patients With LV Dysfunction [Phase 3]

  Phase 3 clinical trial update evaluating ranolazine for arrhythmias and microvolt T-wave alternans in patients with left ventricular dysfunc…