Heart Failure with Reduced Ejection Fraction

• FDA approval · 2025-07-16
  FDA Approved: SACUBITRIL AND VALSARTAN — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved the original application (ANDA213748) for a generic sacubitril/valsartan combination from Novadoz Pharmaceuticals LLC.

• FDA approval · 2025-01-13
  FDA Approved: SACUBITRIL AND VALSARTAN SACUBITRIL AND VALSARTAN — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved Dr. Reddy's Laboratories' Abbreviated New Drug Application for sacubitril/valsartan (sacubitril and valsartan), granting a gene…

• FDA approval · 2024-10-16
  FDA Approved: SACUBITRIL AND VALSARTAN — Original Application (XLCare Pharmaceuticals Inc)

  FDA approved an original application for sacubitril and valsartan from XLCare Pharmaceuticals Inc.

• FDA approval · 2024-01-18
  FDA Approved: BISOPROLOL FUMARATE — Original Application (Harman Finochem Limited)

  FDA approved Harman Finochem Limited's bisoprolol fumarate as an original generic application (ANDA). Bisoprolol fumarate is a beta-blocker …

• FDA approval · 2023-06-02
  FDA Approved: EPLERENONE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' Original Application for a generic version of eplerenone (Inspra).

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• FDA approval · 2022-11-21
  FDA Approved: VERQUVO — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Verquvo (vericiguat) from Merck Sharp & Dohme LLC, updating the drug’s labeling as part of t…

• FDA approval · 2021-12-30
  FDA Approved: IVABRADINE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved the original ANDA for IVABRADINE, allowing Ingenus Pharmaceuticals, LLC to market a generic form of ivabradine in the United St…

• FDA approval · 2021-08-04
  FDA Approved: CORLANOR — Supplemental Application (Amgen Inc)

  The FDA approved a supplemental application for CORLANOR (ivabradine) from Amgen Inc.

• FDA approval · 2017-07-13
  FDA Approved: EPLERENONE — Original Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare's original (ANDA) application for the generic drug eplerenone (Eplerenone). The product is intended for indic…

• FDA approval · 2015-07-07
  FDA Approved: ENTRESTO — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approves ENTRESTO (sacubitril/valsartan) under an original application from Novartis. The drug is indicated for treatment of heart failu…

• FDA approval · 2015-04-15
  FDA Approved: CORLANOR — Original Application (Amgen Inc)

  FDA approves CORLANOR (ivabradine) from Amgen in its original NDA for chronic heart failure with reduced ejection fraction in adults. In add…

• FDA approval · 2012-06-22
  FDA Approved: EPLERENONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for eplerenone filed by Mylan Pharmaceuticals Inc. This action updates regulatory aspects of the…

• FDA approval · 2008-05-07
  FDA Approved: EPLERENONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for EPLERENONE submitted by Mylan Pharmaceuticals Inc.