Heart Failure

• FDA approval · 2016-08-19
  FDA Approved: BISOPROLOL FUMARATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved the supplemental application to market a generic bisoprolol fumarate tablet from Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2016-07-29
  FDA Approved: QBRELIS — Original Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved QBRELIS (lisinopril) through an original NDA from Azurity Pharmaceuticals. It is indicated for hypertension, heart failure,…

• FDA approval · 2016-07-20
  FDA Approved: FUROSEMIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original application for furosemide, authorizing a generic version of this diuretic.

• FDA approval · 2016-07-15
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for metoprolol succinate from BluePoint Laboratories, enabling continued marketing of this generic b…

• FDA approval · 2016-07-13
  FDA Approved: LISINOPRIL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901))

  FDA approved a supplemental application for lisinopril from Heritage Pharmaceuticals (Avet) under ANDA 076102 to authorize the generic produ…

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• FDA approval · 2016-06-30
  FDA Approved: ETHACRYNIC ACID — Original Application (Edenbridge Pharmaceuticals LLC.)

  The FDA approved Edenbridge Pharmaceuticals' original application for Ethacrynic acid, a loop diuretic used to treat edema associated with h…

• FDA approval · 2016-06-14
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for a generic fixed-dose combination of spironolactone and hydrochlorothiazide from Mylan Pharma…

• FDA approval · 2016-06-14
  FDA Approved: BIDIL — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  FDA approved a supplemental application for BIDIL (hydralazine hydrochloride and isosorbide dinitrate) submitted by Azurity Pharmaceuticals,…

• FDA approval · 2016-06-13
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for metoprolol succinate (generic) from Mylan Pharmaceuticals Inc., resulting in labeling changes as…

• FDA approval · 2016-05-31
  FDA Approved: DOBUTAMINE IN DEXTROSE — Supplemental Application (Hospira, Inc.)

  The FDA approved a supplemental application for Dobutamine in Dextrose from Hospira, Inc., adding a new formulation to the product’s approve…

• FDA approval · 2016-05-04
  FDA Approved: EPLERENONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for eplerenone from Mylan Pharmaceuticals, updating the approved product label for this generic …

• FDA approval · 2016-04-26
  FDA Approved: CARVEDILOL — Supplemental Application (Advagen Pharma Ltd)

  FDA approved a supplemental application for carvedilol filed by Advagen Pharma Ltd, resulting in an additional authorization for the product…

• FDA approval · 2016-04-26
  FDA Approved: CARVEDILOL — Supplemental Application (Sandoz Inc)

  FDA approved Sandoz Inc's supplemental application for carvedilol (CARVEDILOL).

• FDA approval · 2016-04-12
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for enalapril maleate from ScieGen Pharmaceuticals, Inc. (ANDA 075178).

• FDA approval · 2016-04-04
  FDA Approved: CARVEDILOL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for carvedilol from Aurobindo Pharma Limited, enabling continued market supply of this generic produ…

• FDA approval · 2016-03-21
  FDA Approved: CARVEDILOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark Pharmaceuticals' supplemental application for carvedilol, clearing a generic formulation for regulatory sale. This…

• FDA approval · 2016-03-08
  FDA Approved: FUROSEMIDE — Supplemental Application (Phlow Corporation)

  FDA approved a supplemental application for furosemide submitted by Phlow Corporation.

• FDA approval · 2016-03-04
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

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

• FDA approval · 2016-02-28
  FDA Approved: RAMIPRIL — Supplemental Application (Chartwell RX, LLC.)

  The FDA has approved a supplemental application for RAMIPRIL, allowing Chartwell RX, LLC to market a RAMIPRIL generic product.

• FDA approval · 2016-02-25
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  The FDA approved a supplemental application for enalapril maleate from Taro Pharmaceuticals U.S.A., Inc., confirming approval of a generic e…

• FDA approval · 2016-02-24
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  The FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC.

• FDA approval · 2016-02-23
  FDA Approved: CAPTOPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for CAPTOPRIL from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2016-02-18
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for carvedilol submitted by Teva Pharmaceuticals USA, Inc., authorizing a generic carvedilol product…

• FDA approval · 2016-02-18
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for enalapril maleate from Northstar RxLLC. The approval confirms changes associated with this gener…

• FDA approval · 2016-02-18
  FDA Approved: QUINAPRIL — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for Quinapril submitted by BluePoint Laboratories. The action updates the drug’s labeling.