Heart Failure

• FDA approval · 2021-10-05
  FDA Approved: VALSARTAN — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approves the original application for valsartan from Dr. Reddy's Laboratories Limited, granting approval for the generic product.

• FDA approval · 2021-10-01
  FDA Approved: RAMIPRIL — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Ramipril from Rising Pharma Holdings, Inc., enabling the continued manufacture and distribut…

• FDA approval · 2021-08-20
  FDA Approved: METOLAZONE — Original Application (Advagen Pharma Limited)

  FDA approved Advagen Pharma Limited's Original Application for METOLAZONE, granting approval of a generic diuretic.

• FDA approval · 2021-08-17
  FDA Approved: LISINOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for lisinopril from Camber Pharmaceuticals, Inc., for the generic product.

• FDA approval · 2021-08-10
  FDA Approved: ENALAPRIL MALEATE ORAL SOLUTION — Original Application (Bionpharma Inc.)

  FDA approved ENALAPRIL MALEATE ORAL SOLUTION from Bionpharma Inc. under Original Application ANDA212408.

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• FDA approval · 2021-08-05
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for enalaprilate maleate from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effecti…

• FDA approval · 2021-08-04
  FDA Approved: CORLANOR — Supplemental Application (Amgen Inc)

  The FDA approved Amgen's supplemental application for CORLANOR (ivabradine).

• FDA approval · 2021-07-16
  FDA Approved: TOLVAPTAN — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' tolvaptan via an original (ANDA) application, indicating a generic tolvaptan product is approved.

• FDA approval · 2021-04-30
  FDA Approved: CANDESARTAN CILEXETIL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for candesartan cilexetil from Mylan Pharmaceuticals Inc.

• FDA approval · 2021-04-22
  FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

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

• FDA approval · 2021-04-16
  FDA Approved: MILRINONE LACTATE — Original Application (Caplin Steriles Limited)

  FDA approved Caplin Steriles Limited's original application for milrinone lactate, a generic intravenous inotrope for acute heart failure.

• FDA approval · 2021-04-02
  FDA Approved: RAMIPRIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for ramipril (generic ACE inhibitor), enabling continued marketing with the…

• FDA approval · 2021-04-02
  FDA Approved: RAMIPRIL — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Ramipril from Rising Pharma Holdings, Inc., indicating an updated approval under the ANDA.

• FDA approval · 2021-03-30
  FDA Approved: METOLAZONE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approves the original ANDA for Metolazone from Unichem Pharmaceuticals (USA), Inc., establishing its generic status.

• FDA approval · 2021-03-30
  FDA Approved: METOLAZONE — Original Application (Method Pharmaceuticals, LLC)

  FDA approved METOLAZONE under an original ANDA from Method Pharmaceuticals, LLC (generic approval).

• FDA approval · 2021-03-04
  FDA Approved: LISINOPRIL — Original Application (Chartwell RX, LLC)

  FDA approves Chartwell RX, LLC’s original application for lisinopril, a generic ACE inhibitor. Lisinopril is used to treat hypertension, con…

• FDA approval · 2021-02-26
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for spironolactone from Mylan Pharmaceuticals, resulting in changes to the product labeling as p…

• FDA approval · 2021-02-26
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for Accord Healthcare's generic spironolactone. This action confirms approval of modifications under…

• FDA approval · 2021-02-26
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  The FDA approved a supplemental application for spironolactone from Oxford Pharmaceuticals, LLC, under the existing ANDA.

• FDA approval · 2021-02-19
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Spironolactone and Hydrochlorothiazide by Prasco Laboratories, authorizing its marketing as …

• FDA approval · 2021-02-16
  FDA Approved: ENTRESTO — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2021-02-12
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Epic Pharma, LLC)

  FDA approves the original application for metoprolol succinate as a generic extended-release beta-blocker indicated for hypertension and hea…

• FDA approval · 2021-01-27
  FDA Approved: FUROSEMIDE — Original Application (Sagent Pharmaceuticals)

  FDA approved a new generic version of furosemide from Sagent Pharmaceuticals under an original application, enabling market entry as a loop …

• FDA approval · 2021-01-13
  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 · 2020-12-22
  FDA Approved: FUROSEMIDE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for furosemide from Marlex Pharmaceuticals, Inc., indicating an additional/or updated approval f…