Atrial Fibrillation

• FDA approval · 2015-08-25
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approves Apotex Corp.'s supplemental application for diltiazem hydrochloride (generic) under an abbreviated new drug application (ANDA).

• FDA approval · 2015-08-25
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Sotalol hydrochloride from Aurobindo Pharma Limited. The approval confirms the generic product's…

• FDA approval · 2015-08-13
  FDA Approved: PACERONE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for PACERONE (amiodarone hydrochloride) from Upsher-Smith Laboratories.

• FDA approval · 2015-08-13
  FDA Approved: PROPAFENONE HCL — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Propafenone hydrochloride (Propafenone HCl) from Actavis Pharma, Inc.

• FDA approval · 2015-07-28
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Digoxin from Hikma Pharmaceuticals USA Inc. for continued marketing of the drug and potential la…

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• FDA approval · 2015-07-28
  FDA Approved: LANOXIN — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approves a supplemental application for LANOXIN (digoxin) from Advanz Pharma (US) Corp., under the supplemental NDA framework.

• FDA approval · 2015-07-08
  FDA Approved: TIKOSYN — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

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

• FDA approval · 2015-07-02
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Advagen Pharma Limited)

  FDA approved a supplemental application for amiodarone hydrochloride by Advagen Pharma Limited. This action confirms regulatory clearance fo…

• 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 · 2015-06-16
  FDA Approved: SOTYLIZE — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for SOTYLIZE (sotalol hydrochloride) from Azurity Pharmaceuticals.

• FDA approval · 2015-05-19
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Amiodarone Hydrochloride (generic) from Chartwell RX, LLC, confirming the generic product's stat…

• 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 · 2015-04-06
  FDA Approved: DIGOXIN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Digoxin, submitted by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2015-03-13
  FDA Approved: NEXTERONE — Supplemental Application (Baxter Healthcare Company)

  The FDA approved a supplemental application for NEXTERONE (amiodarone hydrochloride) from Baxter Healthcare Company.

• FDA approval · 2015-03-02
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (AiPing Pharmaceutical, Inc.)

  FDA approved AiPing Pharmaceutical, Inc.'s supplemental application for sotalol hydrochloride, confirming approval of a generic product's su…

• FDA approval · 2015-02-23
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Digoxin submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2015-02-17
  FDA Approved: FLECAINIDE ACETATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for flecainide acetate from Hikma Pharmaceuticals USA Inc., expanding or authorizing changes to this…

• FDA approval · 2015-01-26
  FDA Approved: BREVIBLOC — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved a supplemental application for Brevibloc (esmolol hydrochloride) submitted by Baxter Healthcare Corporation.

• FDA approval · 2014-12-21
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for amiodarone hydrochloride submitted by Sun Pharmaceutical Industries, signifying a regulatory…

• FDA approval · 2014-12-21
  FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for amiodarone hydrochloride from Sun Pharmaceutical Industries, Inc., indicating regulatory approva…

• FDA approval · 2014-10-28
  FDA Approved: METOPROLOL TARTRATE — Original Application (TRUPHARMA LLC)

  FDA approved TRUPHARMA LLC's original ANDA for metoprolol tartrate, enabling a generic version of this beta-blocker. The approval makes meto…

• FDA approval · 2014-10-22
  FDA Approved: SOTYLIZE — Original Application (Azurity Pharmaceuticals, Inc.)

  FDA approved SOTYLIZE (sotalol hydrochloride) through an Original NDA from Azurity Pharmaceuticals for antiarrhythmic use.

• 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…

• FDA approval · 2014-07-03
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for DIGOXIN from Hikma Pharmaceuticals USA Inc., resulting in changes to the approved product labeli…

• FDA approval · 2014-06-09
  FDA Approved: CORVERT — Supplemental Application (Pharmacia & Upjohn Company LLC)

  FDA approved a supplemental application for CORVERT (ibutilide fumarate) filed by Pharmacia & Upjohn Company LLC, signaling a regulatory upd…