Heart Failure

• FDA approval · 2019-10-01
  FDA Approved: ENTRESTO — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2019-09-26
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  The FDA approved a supplemental application for lisinopril filed by Solco Healthcare U.S., LLC under an ANDA. The action authorizes changes …

• FDA approval · 2019-09-20
  FDA Approved: VALSARTAN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves a supplemental application for VALSARTAN by Amneal Pharmaceuticals LLC (ANDA 204011) to support the generic product.

• FDA approval · 2019-09-13
  FDA Approved: VALSARTAN — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for valsartan from Alembic Pharmaceuticals Limited (ANDA 091367).

• FDA approval · 2019-09-06
  FDA Approved: ETHACRYNIC ACID — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals, Inc.'s Original Application for Ethacrynic acid, authorizing a generic version of the loop diuretic. Thi…

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• FDA approval · 2019-09-04
  FDA Approved: VALSARTAN — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for VALSARTAN submitted by Macleods Pharmaceuticals Limited, indicating approval of changes to t…

• FDA approval · 2019-09-03
  FDA Approved: VALSARTAN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for valsartan, a generic angiotensin II receptor blocker, for approved labeling…

• FDA approval · 2019-09-03
  FDA Approved: VALSARTAN — Supplemental Application (SQUARE PHARMACEUTICALS LIMITED)

  FDA approved a supplemental application for valsartan submitted by Square Pharmaceuticals Limited. This approval pertains to the generic pro…

• FDA approval · 2019-08-27
  FDA Approved: ETHACRYNIC ACID — Original Application (ScieGen Pharmaceuticals Inc)

  FDA approved Ethacrynic acid from ScieGen Pharmaceuticals Inc under an Original Application (ANDA211232).

• FDA approval · 2019-08-20
  FDA Approved: VALSARTAN — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for VALSARTAN submitted by Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2019-08-07
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approves a supplemental application for enalapril maleate by Taro Pharmaceuticals U.S.A., Inc., pertaining to an approved product (gener…

• FDA approval · 2019-08-06
  FDA Approved: CHLORTHALIDONE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved the original application for chlorthalidone from Unichem Pharmaceuticals (USA), Inc., enabling a generic version of the diureti…

• FDA approval · 2019-08-05
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's supplemental application for spironolactone, enabling the marketing of a new generic product.

• FDA approval · 2019-07-25
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for spironolactone submitted by Sun Pharmaceutical Industries, Inc., indicating an update to the…

• FDA approval · 2019-07-12
  FDA Approved: ETHACRYNIC ACID — Original Application (TRUPHARMA LLC)

  FDA approves the original ANDA for Ethacrynic acid by Trupharma LLC, enabling its generic distribution as a loop diuretic. The approval cove…

• FDA approval · 2019-06-12
  FDA Approved: DIOVAN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for DIOVAN (valsartan) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2019-05-24
  FDA Approved: DOBUTAMINE IN DEXTROSE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Dobutamine in Dextrose from Hospira, Inc.

• FDA approval · 2019-05-19
  FDA Approved: BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for benazepril hydrochloride submitted by Amneal Pharmaceuticals of New York LLC, indicating an …

• FDA approval · 2019-05-13
  FDA Approved: CORLANOR — Supplemental Application (Amgen Inc)

  FDA approved Amgen's supplemental application for CORLANOR (ivabradine), updating the product's labeling.

• FDA approval · 2019-05-03
  FDA Approved: FUROSEMIDE — Original Application (Eugia US LLC)

  FDA approved an original ANDA for FUROSEMIDE by Eugia US LLC, confirming a generic version of the diuretic. This is a routine generic drug a…

• FDA approval · 2019-04-24
  FDA Approved: BUMETANIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for Bumetanide from Upsher-Smith Laboratories, LLC.

• FDA approval · 2019-04-22
  FDA Approved: CORLANOR — Original Application (Amgen Inc)

  The FDA approved CORLANOR (ivabradine) under Amgen's original NDA, marking the initial approval of the product for its indicated use.

• FDA approval · 2019-03-12
  FDA Approved: BIDIL — Supplemental Application (Azurity Pharmaceuticals, Inc.)

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

• FDA approval · 2019-03-12
  FDA Approved: VALSARTAN — Original Application (Ascend Laboratories, LLC)

  FDA approved the original application for valsartan from Ascend Laboratories, making a generic ARB available. It covers indications includin…

• FDA approval · 2019-03-06
  FDA Approved: CARVEDILOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark Pharmaceuticals Inc., USA's supplemental application for carvedilol (generic). The action confirms regulatory approval…