Heart Failure

• FDA approval · 2024-01-10
  FDA Approved: PERINDOPRIL ERBUMINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Perindopril Erbumine from Aurobindo Pharma Limited.

• FDA approval · 2024-01-08
  FDA Approved: ENALAPRIL MALEATE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for enalapril maleate from Aurobindo Pharma Limited, a generic version of enalapril for cardiovascular…

• FDA approval · 2023-12-27
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for metoprolol succinate (Toprol-XL) under an ANDA from Nivagen Pharmaceuticals.

• FDA approval · 2023-11-29
  FDA Approved: IVABRADINE — Original Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved an Original Application for IVABRADINE from Zydus Pharmaceuticals USA Inc., authorizing a generic IVABRADINE product.

• FDA approval · 2023-11-01
  FDA Approved: CARVEDILOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's supplemental application for carvedilol, allowing continued marketing of the generic product.

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• FDA approval · 2023-10-18
  FDA Approved: ENTRESTO — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for ENTRESTO (sacubitril and valsartan) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2023-10-10
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for spironolactone by Mylan Pharmaceuticals Inc., updating the approval for this generic diuretic. T…

• FDA approval · 2023-10-06
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Hydralazine Hydrochloride (generic) from Heritage Pharmaceuticals (d/b/a Avet Pharmaceutical…

• FDA approval · 2023-09-26
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for metoprolol succinate from Nivagen Pharmaceuticals, Inc., authorizing changes to the product'…

• FDA approval · 2023-09-12
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for metoprolol succinate from Mylan Pharmaceuticals Inc.

• FDA approval · 2023-09-11
  FDA Approved: ACETAZOLAMIDE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s original application for acetazolamide (generic).

• FDA approval · 2023-09-08
  FDA Approved: DOBUTAMINE HYDROCHLORIDE IN DEXTROSE — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE (Baxter).

• FDA approval · 2023-09-05
  FDA Approved: SPIRONOLACTONE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the original ANDA for spironolactone from Amneal Pharmaceuticals NY LLC, enabling a generic version of the diuretic.

• FDA approval · 2023-08-24
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for spironolactone from Padagis US LLC, indicating an updated regulatory action on this product (sup…

• FDA approval · 2023-08-07
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Granules India Ltd)

  FDA approved METOPROLOL SUCCINATE (extended-release) as an original generic application from Granules India Ltd, enabling its marketing for …

• FDA approval · 2023-07-26
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC.

• FDA approval · 2023-07-24
  FDA Approved: BUMETANIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' original ANDA for bumetanide, a loop diuretic used to treat edema and related conditions.

• FDA approval · 2023-07-21
  FDA Approved: TORSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for torsemide, granting approval of a generic torsemide product u…

• FDA approval · 2023-06-28
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for Spironolactone from Amneal Pharmaceuticals LLC.

• FDA approval · 2023-06-23
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approved a supplemental application for spironolactone by Oxford Pharmaceuticals, LLC. The approval allows continued marketing of the ge…

• FDA approval · 2023-06-12
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Granules Pharmaceuticals Inc.)

  FDA approved the Original Application (ANDA216916) for Metoprolol succinate, a generic version manufactured by Granules Pharmaceuticals Inc.

• FDA approval · 2023-06-07
  FDA Approved: CANDESARTAN — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for candesartan by Macleods Pharmaceuticals Limited, enabling the marketed generic candesartan produ…

• FDA approval · 2023-06-05
  FDA Approved: DEFINITY — Supplemental Application (Lantheus Medical Imaging, Inc.)

  FDA approved a supplemental application for DEFINITY (perflutren) submitted by Lantheus Medical Imaging, Inc.

• FDA approval · 2023-05-26
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for metoprolol succinate from BluePoint Laboratories, allowing continued manufacture of the gene…

• FDA approval · 2023-05-17
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Sun Pharmaceutical's spironolactone and hydrochlorothiazide combination product. The submission …