Heart Failure

• FDA approval · 2019-02-26
  FDA Approved: CHLORTHALIDONE — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's original application for chlorthalidone, a generic diuretic. This enables marketing of the generic chlo…

• FDA approval · 2019-02-22
  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 · 2018-12-19
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Oryza Pharmaceuticals, Inc)

  The FDA approved Oryza Pharmaceuticals' generic metoprolol succinate product, an extended-release beta-blocker used to treat hypertension, a…

• FDA approval · 2018-12-04
  FDA Approved: CANDESARTAN CILEXETIL — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved the original application for candesartan cilexetil from Alembic Pharmaceuticals Limited, enabling a generic version of the anti…

• FDA approval · 2018-10-30
  FDA Approved: HYDRALAZINE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Hydralazine Hydrochloride (HYDRALAZINE HYDROCHLORIDE) from Nivagen Pharmaceuticals, Inc. under a…

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• FDA approval · 2018-10-29
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  The FDA approved a supplemental application for metoprolol succinate submitted by Zydus Pharmaceuticals (USA) Inc., updating the labeling fo…

• FDA approval · 2018-10-26
  FDA Approved: FARXIGA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Farxiga (dapagliflozin) from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2018-10-26
  FDA Approved: METOPROLOL SUCCINATE — Original Application (BluePoint Laboratories)

  FDA approved a generic metoprolol succinate product from BluePoint Laboratories under an original ANDA for the treatment of hypertension, an…

• FDA approval · 2018-10-12
  FDA Approved: CHLORTHALIDONE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved Dr. Reddy's Laboratories Inc.'s original application for chlorthalidone (generic diuretic) under ANDA210742.

• FDA approval · 2018-09-14
  FDA Approved: EPLERENONE — Original Application (Breckenridge Pharmaceutical, Inc.)

  FDA approved Breckenridge Pharmaceutical's original ANDA for eplerenone (generic), a mineralocorticoid receptor antagonist used to treat hea…

• FDA approval · 2018-08-24
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Digoxin (DIGOXIN) from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2018-08-08
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for LASIX (furosemide) from Validus Pharmaceuticals LLC.

• FDA approval · 2018-08-01
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (OCEANSIDE PHARMACEUTICALS)

  FDA approved a supplemental application for enalapril maleate from Oceanside Pharmaceuticals, indicating an updated/expanded labeling for th…

• FDA approval · 2018-07-30
  FDA Approved: NITROGLYCERIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Nitroglycerin submitted by Prasco Laboratories, signaling an approval-related action affecting t…

• FDA approval · 2018-07-19
  FDA Approved: QUINAPRIL — Supplemental Application (BluePoint Laboratories)

  FDA has approved a supplemental application for Quinapril submitted by BluePoint Laboratories. The action updates the regulatory status of t…

• FDA approval · 2018-07-18
  FDA Approved: SPIRONOLACTONE — Original Application (Zydus Lifesciences Limited)

  FDA approved the Original Application (ANDA) for spironolactone from Zydus Lifesciences Limited, marking a generic version of the diuretic.

• FDA approval · 2018-06-08
  FDA Approved: QUINAPRIL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Quinapril Hydrochloride from Aurobindo Pharma Limited. This approval pertains to the generic…

• FDA approval · 2018-05-08
  FDA Approved: ETHACRYNIC ACID — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the original generic application for Ethacrynic acid from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2018-05-07
  FDA Approved: CARVEDILOL PHOSPHATE — Original Application (AvKARE)

  FDA approved AvKARE's Carvedilol Phosphate as a generic original application, granting market approval for this salt form of carvedilol.

• FDA approval · 2018-05-04
  FDA Approved: VALSARTAN — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approves the original (generic) application for valsartan from Unichem Pharmaceuticals (USA), Inc., making a generic valsartan product a…

• FDA approval · 2018-04-30
  FDA Approved: BUMETANIDE — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved Bumetanide as a generic via Original Application (ANDA 202900), confirming bioequivalence to the reference product. It is indic…

• FDA approval · 2018-04-23
  FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved a supplemental application for Samsca (tolvaptan) from Otsuka America Pharmaceutical.

• FDA approval · 2018-04-17
  FDA Approved: SODIUM NITROPRUSSIDE — Original Application (Mylan Institutional LLC)

  FDA approved the original application for sodium nitroprusside from Mylan Institutional LLC, introducing a generic version of this vasodilat…

• FDA approval · 2018-04-09
  FDA Approved: VALSARTAN — Original Application (SQUARE PHARMACEUTICALS LIMITED)

  The FDA approved Square Pharmaceuticals Limited's original application for valsartan (generic valsartan).

• FDA approval · 2018-03-23
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved the original application for METOPROLOL SUCCINATE (generic) from Zydus Pharmaceuticals (USA) Inc., authorizing its marketing as…