Heart Failure

• FDA approval · 2025-06-05
  FDA Approved: VALSARTAN — Original Application (Advagen Pharma Ltd)

  FDA approved the original application for a generic valsartan oral tablet from Advagen Pharma Ltd.

• FDA approval · 2025-06-02
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approves the Original Application for Hydralazine hydrochloride as a generic product by Meitheal Pharmaceuticals Inc.

• FDA approval · 2025-05-08
  FDA Approved: FUROSEMIDE — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for furosemide by Eugia US LLC under an ANDA, confirming approval of the supplement.

• FDA approval · 2025-04-14
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

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

• FDA approval · 2025-04-03
  FDA Approved: BUMETANIDE — Original Application (First Nation Group, LLC)

  FDA approves bumetanide under an Original Application filed by First Nation Group, LLC (ANDA219291).

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• FDA approval · 2025-03-19
  FDA Approved: CARVEDILOL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for carvedilol from Quallent Pharmaceuticals Health LLC.

• FDA approval · 2025-03-07
  FDA Approved: BISOPROLOL FUMARATE — Supplemental Application (TruPharma LLC)

  FDA approved a supplemental application for Bisoprolol Fumarate from TruPharma LLC, validating the generic product under ANDA075643.

• FDA approval · 2025-02-27
  FDA Approved: BUMETANIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for bumetanide, a loop diuretic used to treat edema due to congestive heart failur…

• FDA approval · 2025-02-21
  FDA Approved: SPIRONOLACTONE — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' original application for spironolactone, establishing a generic version of the diuretic. Spironolac…

• FDA approval · 2025-01-28
  FDA Approved: INZIRQO — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved INZIRQO, a brand-name hydrochlorothiazide, under ANI Pharmaceuticals' original application.

• FDA approval · 2025-01-23
  FDA Approved: SPIRONOLACTONE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved the original application for spironolactone (generic) from Rising Pharma Holdings, Inc., authorizing the marketing of a gen…

• FDA approval · 2025-01-08
  FDA Approved: SACUBITRIL AND VALSARTAN — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original application for a generic sacubitril/valsartan product, enabling access to this heart failure t…

• FDA approval · 2024-12-27
  FDA Approved: BUMETANIDE — Original Application (Advagen Pharma Limited)

  FDA approved Advagen Pharma Limited's original ANDA for bumetanide, a loop diuretic used to treat edema associated with congestive heart fai…

• FDA approval · 2024-12-16
  FDA Approved: NITROGLYCERIN — Original Application (Encube Ethicals, Inc.)

  The FDA approved Encube Ethicals, Inc.'s generic nitroglycerin product under an Original Application (ANDA216452). This approval provides a …

• FDA approval · 2024-12-13
  FDA Approved: FUROSEMIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for furosemide, enabling a generic version of the loop diuretic to be marketed.

• 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 …

• FDA approval · 2024-11-08
  FDA Approved: IVABRADINE — Original Application (Alembic Pharmaceuticals Limited)

  The FDA approved Alembic Pharmaceuticals Limited's original application for a generic IVABRADINE product.

• FDA approval · 2024-11-06
  FDA Approved: METOLAZONE — Original Application (Micro Labs Limited)

  The FDA approved the generic METOLAZONE from Micro Labs Limited under an Original Application. This metolazone product is a thiazide-like di…

• FDA approval · 2024-10-01
  FDA Approved: FUROSEMIDE — Supplemental Application (Phlow Corporation)

  The FDA approved a supplemental application for furosemide from Phlow Corporation, authorizing an additional or revised approval for the diu…

• FDA approval · 2024-09-24
  FDA Approved: CARVEDILOL — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for carvedilol by Sandoz Inc. This is a supplemental approval for a generic carvedilol product.

• FDA approval · 2024-09-19
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for hydrochlorothiazide from Teva Pharmaceuticals USA, Inc. The approval concerns regulatory changes…

• FDA approval · 2024-09-19
  FDA Approved: ENALAPRIL MALEATE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the generic enalapril maleate from Rising Pharma Holdings under an Original Application (ANDA 218531).

• FDA approval · 2024-09-19
  FDA Approved: BUMETANIDE — Original Application (Qilu Pharmaceutical Co., Ltd.)

  FDA approved bumetanide (Original Application) by Qilu Pharmaceutical as a generic diuretic for edema associated with congestive heart failu…

• FDA approval · 2024-09-17
  FDA Approved: BUMETANIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' bumetanide original application, granting a generic diuretic for edema associated with congestive he…

• FDA approval · 2024-09-16
  FDA Approved: SACUBITRIL AND VALSARTAN — Original Application (Ascend Laboratories, LLC)

  FDA approved Sacubitril and Valsartan as an Original Application from Ascend Laboratories, LLC. This marks the introduction of a sacubitril/…