Heart Failure

• EMA approval · 2024-09-06
  EMA Authorised: Ivabradine Accord (ivabradine hydrochloride) — Accord Healthcare S.L.U.

  The EMA authorised Ivabradine Accord (ivabradine hydrochloride) from Accord Healthcare S.L.U. for the treatment of angina pectoris and heart…

• FDA approval · 2024-08-30
  FDA Approved: SACUBITRIL AND VALSARTAN — Original Application (Biocon Pharma Inc.)

  FDA approved Biocon Pharma Inc.'s original application for a generic sacubitril/valsartan tablet, enabling a generic version of the heart fa…

• FDA approval · 2024-08-23
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for carvedilol (generic), indicating regulatory approval related to t…

• FDA approval · 2024-08-22
  FDA Approved: SACUBITRIL AND VALSARTAN — Original Application (Torrent Pharmaceuticals Limited)

  FDA approves Torrent Pharmaceuticals Limited's original ANDA for sacubitril and valsartan tablets, a generic version of the heart failure me…

• 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.

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• FDA approval · 2024-07-26
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Oryza pharmaceuticals Inc.)

  FDA approved a generic metoprolol succinate product from Oryza Pharmaceuticals Inc. via an Original Application (ANDA).

• FDA approval · 2024-07-22
  FDA Approved: VALSARTAN — Original Application (Zydus Lifesciences Limited)

  FDA granted original approval for VALSARTAN (Valsartan) by Zydus Lifesciences Limited as a generic product under ANDA 218991.

• FDA approval · 2024-07-09
  FDA Approved: SACUBITRIL AND VALSARTAN — Original Application (Zydus Lifesciences Limited)

  FDA approved Zydus Lifesciences Limited's original ANDA for sacubitril/valsartan as a generic product.

• FDA approval · 2024-07-08
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for Losartan Potassium by Quallent Pharmaceuticals Health LLC, indicating approval of an additional …

• FDA approval · 2024-07-08
  FDA Approved: CAPTOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for CAPTOPRIL (captopril), a generic ACE inhibitor.

• FDA approval · 2024-06-28
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (BluePoint Laboratories)

  FDA approves a supplemental application for metoprolol succinate from BluePoint Laboratories to bring a generic version to market.

• 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 · 2024-05-28
  FDA Approved: SACUBITRIL AND VALSARTAN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approves a generic sacubitril/valsartan product from Amneal Pharmaceuticals NY LLC under an original ANDA; the drug is indicated for tre…

• FDA approval · 2024-05-28
  FDA Approved: SACUBITRIL AND VALSARTAN — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals Limited's original application for a generic fixed-dose combination of sacubitril and valsartan.

• FDA approval · 2024-05-28
  FDA Approved: SACUBITRIL AND VALSARTAN — Original Application (Laurus Labs Limited)

  FDA approves Laurus Labs Limited's original application for a generic sacubitril/valsartan product.

• 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 · 2024-04-16
  FDA Approved: CARVEDILOL PHOSPHATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for carvedilol phosphate from Sun Pharmaceutical, confirming approval of this generic salt formulati…

• FDA approval · 2024-04-12
  FDA Approved: ENTRESTO — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approved ENTRESTO (sacubitril/valsartan) under the original application to treat chronic heart failure and reduce cardiovascular death i…

• FDA approval · 2024-04-12
  FDA Approved: ENTRESTO — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for ENTRESTO (sacubitril/valsartan) from Novartis Pharmaceuticals, resulting in changes to its label…

• FDA approval · 2024-04-02
  FDA Approved: FUROSEMIDE — Original Application (Devatis Inc.)

  FDA approved Devatis Inc.'s original application for a generic furosemide product, enabling its marketing in the United States.

• FDA approval · 2024-03-06
  FDA Approved: DOBUTAMINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for the dobutamine product from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2024-03-01
  FDA Approved: DEFINITY — Supplemental Application (Lantheus Medical Imaging, Inc.)

  FDA approved a supplemental application for DEFINITY (perflutren) from Lantheus Medical Imaging, Inc., resulting in updated labeling and/or …

• FDA approval · 2024-01-30
  FDA Approved: ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE — Supplemental Application (A2A Integrated Pharmaceuticals)

  FDA approved a supplemental application for Isosorbide Dinitrate and Hydralazine Hydrochloride from A2A Integrated Pharmaceuticals.

• FDA approval · 2024-01-22
  FDA Approved: VALSARTAN — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application from Unichem Pharmaceuticals (USA), Inc. for valsartan (generic valsartan) under an ANDA.

• FDA approval · 2024-01-17
  FDA Approved: ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE — Original Application (A2A Integrated Pharmaceuticals)

  FDA approved a generic fixed-dose combination of isosorbide dinitrate and hydralazine hydrochloride for heart failure, manufactured by A2A I…