Cardiac Arrhythmia

• FDA approval · 2008-02-25
  FDA Approved: AMIODARONE HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc. amiodarone hydrochloride generic (ANDA 077234), providing a generic option for the treatment of …

• CLINICAL_TRIALS trial_result · 2007-12-10
  Clinical Trial Update: Study Evaluating GAP-486 in Heart Rhythm [Phase 2]

  Phase 2 trial evaluating GAP-486 for cardiac arrhythmias has been terminated.

• CLINICAL_TRIALS trial_result · 2007-11-20
  Clinical Trial Update: Magnesium to Reduce Implantable Cardioverter Defibrillator (ICD) Shocks and Improve Patient's Quality of Life. [Phase 4]

  Phase 4 clinical trial update evaluating whether magnesium supplementation reduces implantable cardioverter-defibrillator shocks and improve…

• FDA approval · 2007-11-07
  FDA Approved: FLECAINIDE ACETATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for flecainide acetate from Hikma Pharmaceuticals USA Inc., approving changes to the approved generi…

• FDA approval · 2007-10-15
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for amiodarone hydrochloride submitted by Mylan Institutional LLC.

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• FDA approval · 2007-08-10
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)

  The FDA approved Actavis Pharma's generic propranolol hydrochloride product in an Original ANDA submission.

• FDA approval · 2007-04-12
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Dr. Reddy's Labratories Inc.)

  FDA approved a supplemental application for amiodarone hydrochloride from Dr. Reddy's Laboratories Inc.

• FDA approval · 2007-04-11
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for amiodarone hydrochloride (generic) submitted by Chartwell RX, LLC.

• FDA label_change · 2007-02-21
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approves a supplemental application for Inderal LA (propranolol hydrochloride) submitted by ANI Pharmaceuticals, Inc., resulting in labe…

• FDA approval · 2007-01-03
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INDERAL LA (propranolol hydrochloride) submitted by ANI Pharmaceuticals, Inc. This action au…