Atrial Fibrillation

• FDA approval · 2025-02-24
  FDA Approved: DOFETILIDE — Supplemental Application (Dr. Reddy's Labratories Inc.)

  FDA approved a supplemental application for the generic DOFETILIDE from Dr. Reddy's Labratories Inc., authorizing the generic product.

• FDA approval · 2025-02-21
  FDA Approved: NEXTERONE — Supplemental Application (Baxter Healthcare Company)

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

• FDA approval · 2025-02-21
  FDA Approved: DILTIAZEM HYDROCHLORIDE IN SODIUM CHLORIDE — Original Application (WG Critical Care, LLC)

  FDA approved a new injectable diltiazem hydrochloride in sodium chloride under an original NDA from WG Critical Care, LLC. This parenteral f…

• FDA approval · 2025-02-04
  FDA Approved: PROCAINAMIDE HYDROCHLORIDE — Original Application (Caplin Steriles Limited)

  FDA approved Caplin Steriles Limited's original ANDA for Procainamide hydrochloride, a generic antiarrhythmic drug.

• FDA approval · 2024-11-19
  FDA Approved: DIGOXIN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals, Inc.'s supplemental application for Digoxin, granting regulatory approval for an update to an already …

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• FDA approval · 2024-10-18
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' generic diltiazem hydrochloride under an Original Application (ANDA).

• FDA approval · 2024-10-17
  FDA Approved: PROPAFENONE HYDROCHLORIDE — Supplemental Application (Strides Pharma Science Limited)

  The FDA approved a supplemental application for Propafenone Hydrochloride filed by Strides Pharma Science Limited, adding a approved generic…

• FDA approval · 2024-10-15
  FDA Approved: ESMOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA supplemental approval for Amneal's esmolol hydrochloride in sodium chloride, a generic injectable product.

• FDA approval · 2024-09-12
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for diltiazem hydrochloride by Mylan Pharmaceuticals Inc. under ANDA074910, indicating regulatory ap…

• FDA approval · 2024-09-11
  FDA Approved: AMIODARONE HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals)

  FDA approved the original application for Amiodarone hydrochloride (Slate Run Pharmaceuticals) as a generic antiarrhythmic agent.

• FDA approval · 2024-09-09
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Verapamil Hydrochloride (Hospira, Inc.), confirming it as an approved generic drug under an ANDA…

• FDA approval · 2024-08-21
  FDA Approved: DIGOXIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Digoxin submitted by Aurobindo Pharma Limited.

• FDA approval · 2024-07-16
  FDA Approved: MATZIM LA — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for MATZIM LA (diltiazem hydrochloride) from Actavis Pharma, Inc.

• FDA approval · 2024-07-11
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for propranolol hydrochloride by Lannett Company, Inc., approving changes to the existing ANDA to su…

• FDA approval · 2024-07-09
  FDA Approved: ESMOLOL HYDROCHLORIDE — Supplemental Application (Eugia US LLC)

  The FDA approved a supplemental application for esmolol hydrochloride from Eugia US LLC, authorizing changes to the approved product under a…

• FDA approval · 2024-07-09
  FDA Approved: ESMOLOL HYDROCHLORIDE — Supplemental Application (Eugia US LLC)

  The FDA approved a supplemental application for esmolol hydrochloride in sodium chloride (Esmolol Hydrochloride in Sodium Chloride) filed by…

• FDA approval · 2024-06-20
  FDA Approved: LANOXIN — Supplemental Application (Covis Pharma US, Inc)

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

• FDA approval · 2024-05-15
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's supplemental application for sotalol hydrochloride (generic). This action authorizes changes to the previously approved …

• FDA approval · 2024-04-30
  FDA Approved: SOTALOL HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for sotalol hydrochloride from Aurobindo Pharma Limited, authorizing the generic product's approval.

• FDA approval · 2024-04-30
  FDA Approved: DOFETILIDE 0.125MG — Supplemental Application (Granules Pharmaceuticals Inc.)

  FDA approved a supplemental application for dofetilide 0.125 mg (granules) by Granules Pharmaceuticals Inc., expanding the product's availab…

• FDA approval · 2024-04-29
  FDA Approved: LANOXIN — Supplemental Application (Advanz Pharma (US) Corp.)

  The FDA approved a supplemental application for LANOXIN (digoxin) submitted by Advanz Pharma (US) Corp.

• FDA approval · 2024-04-23
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (FRESENIUS KABI USA, LLC)

  FDA approved the original application for Verapamil hydrochloride as a generic drug, manufactured by Fresenius Kabi USA, LLC. Verapamil hydr…

• FDA approval · 2024-04-01
  FDA Approved: IBUTILIDE FUMARATE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved an original ANDA for ibutilide fumarate (generic) from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

• FDA approval · 2024-01-12
  FDA Approved: SOTYLIZE — Supplemental Application (Azurity Pharmaceuticals, Inc.)

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

• FDA approval · 2023-10-23
  FDA Approved: MULTAQ — Supplemental Application (Sanofi-Aventis U.S. LLC)

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