Heart Failure

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

  FDA approved a supplemental application for Enalapril Maleate from Northstar RxLLC under an ANDA.

• FDA approval · 2016-02-16
  FDA Approved: RAMIPRIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for Ramipril (generic ACE inhibitor) under ANDA 077626, enabling a generic …

• FDA approval · 2016-02-16
  FDA Approved: CAPTOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' supplemental application for CAPTOPRIL (captopril) under an existing ANDA. The action confirms continue…

• FDA approval · 2016-02-12
  FDA Approved: ENTRESTO — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for ENTRESTO (sacubitril and valsartan) from Novartis Pharmaceuticals, resulting in labeling updates…

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

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

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• FDA approval · 2016-01-26
  FDA Approved: FOSINOPRIL SODIUM — Supplemental Application (Cipla USA Inc.)

  The FDA approved a supplemental application for fosinopril sodium (fosinopril) submitted by Cipla USA Inc., enabling continued marketing of …

• FDA approval · 2016-01-12
  FDA Approved: JARDIANCE — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approves a supplemental application for Jardiance (empagliflozin) submitted by Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2016-01-11
  FDA Approved: VALSARTAN — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal Pharmaceuticals LLC's Original Application for VALSARTAN, authorizing the marketing of a generic valsartan product.

• FDA approval · 2016-01-10
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Digoxin from Hikma Pharmaceuticals USA Inc., indicating a supplemental approval (AP) for the pro…

• FDA approval · 2016-01-04
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC, supporting continued availability of the generic ACE…

• FDA approval · 2015-12-17
  FDA Approved: VALSARTAN — Supplemental Application (Ohm Laboratories Inc.)

  FDA approved a supplemental application for VALSARTAN from Ohm Laboratories Inc. (ANDA077492).

• FDA approval · 2015-12-16
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for metoprolol succinate by Quallent Pharmaceuticals Health LLC, indicating approval of the suppleme…

• FDA approval · 2015-12-11
  FDA Approved: VALSARTAN — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for VALSARTAN submitted by Alembic Pharmaceuticals Limited.

• FDA approval · 2015-11-25
  FDA Approved: QUINAPRIL — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for Quinapril by Cipla USA Inc., indicating an approval of an additional Quinapril product or labeli…

• FDA approval · 2015-11-24
  FDA Approved: QUINAPRIL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Quinapril hydrochloride from Aurobindo Pharma Limited, enabling the generic product Quinapril hy…

• FDA approval · 2015-11-20
  FDA Approved: VALSARTAN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for valsartan submitted by Lupin Pharmaceuticals, Inc.

• FDA approval · 2015-11-18
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (GSMS, Incorporated)

  FDA approved a supplemental application for the lisinopril and hydrochlorothiazide combination from GSMS, Incorporated.

• FDA approval · 2015-11-09
  FDA Approved: VALSARTAN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for valsartan from Aurobindo Pharma Limited, allowing changes to the approved generic product.

• FDA approval · 2015-10-30
  FDA Approved: VALSARTAN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for VALSARTAN by Mylan Pharmaceuticals Inc.

• FDA approval · 2015-10-02
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG CR (carvedilol phosphate) from Waylis Therapeutics LLC, approving the controlled-release f…

• FDA approval · 2015-10-02
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC.

• FDA approval · 2015-09-28
  FDA Approved: BUMEX — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for Bumex (bumetanide) filed by Validus Pharmaceuticals LLC.

• EMA approval · 2015-09-25
  New medicine to treat heart failure recommended for approval

  The European Medicines Agency recommends approval of a new medicine for treating heart failure in adults, indicating a potential new option …

• FDA approval · 2015-09-16
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for HYDROCHLOROTHIAZIDE from Actavis Pharma, Inc., indicating an approved change to the product labe…

• FDA approval · 2015-09-03
  FDA Approved: LANOXIN — Supplemental Application (Advanz Pharma (US) Corp.)

  The FDA approved a supplemental application for Lanoxin (digoxin) from Advanz Pharma US Corp., associated with NDA 020405. The supplement ma…