Heart Failure

• FDA approval · 2014-09-21
  FDA Approved: CARVEDILOL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for carvedilol from Aurobindo Pharma Limited, confirming a generic version under ANDA078332.

• FDA approval · 2014-09-19
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' supplemental application for Losartan Potassium (generic), granting a supplemental approval for the prod…

• FDA approval · 2014-09-18
  FDA Approved: HYDRALAZINE — Original Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved the original generic application for hydralazine hydrochloride tablets from Nivagen Pharmaceuticals, Inc., for the treatment of…

• FDA approval · 2014-09-17
  FDA Approved: CARVEDILOL — Supplemental Application (UNICHEM PHARMACEUTICALS (USA), INC.)

  The FDA approved a supplemental application for carvedilol, submitted by Unichem Pharmaceuticals (USA), Inc. Carvedilol is a beta-blocker us…

• FDA approval · 2014-09-04
  FDA Approved: TRANDOLAPRIL — Supplemental Application (Epic Pharma, LLC)

  FDA approved a supplemental application for Trandolapril tablets from Epic Pharma, LLC.

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• FDA approval · 2014-09-03
  FDA Approved: MILRINONE LACTATE — Original Application (Hospira, Inc.)

  FDA approved Hospira's milrinone lactate injection as an original ANDA, granting a generic version of milrinone lactate.

• FDA approval · 2014-08-26
  FDA Approved: FUROSEMIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved Heritage Pharmaceuticals' generic furosemide (ANDA 203428) for edema-related indications and hypertension, enabling a generic v…

• FDA approval · 2014-07-23
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved the original application for Hydrochlorothiazide (ScieGen Pharmaceuticals, Inc.), a generic diuretic. It is indicated for hyper…

• FDA approval · 2014-07-03
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for DIGOXIN from Hikma Pharmaceuticals USA Inc., resulting in changes to the approved product labeli…

• FDA approval · 2014-06-26
  FDA Approved: VALSARTAN — Original Application (Ohm Laboratories Inc.)

  FDA approved Ohm Laboratories Inc.'s valsartan under an Original Abbreviated New Drug Application (ANDA), establishing a generic version of …

• FDA approval · 2014-06-13
  FDA Approved: LISINOPRIL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA granted a supplemental approval for lisinopril under ANDA077622 for Aurobindo Pharma Limited.

• FDA approval · 2014-04-23
  FDA Approved: SPIRONOLACTONE — Original Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved the original ANDA for spironolactone, authorizing a generic version manufactured by Jubilant Cadista Pharmaceuticals Inc.

• FDA approval · 2014-03-06
  FDA Approved: SPIRONOLACTONE — Original Application (NorthStar Rx LLC)

  The FDA approved NorthStar Rx LLC's Original Application for spironolactone (generic spironolactone).

• FDA approval · 2014-02-26
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (GSMS, Incorporated)

  FDA approved a supplemental application for the generic fixed-dose combination of lisinopril and hydrochlorothiazide (GSMS, Incorporated).

• FDA approval · 2014-02-26
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a generic lisinopril and hydrochlorothiazide combination tablet from Aurobindo Pharma Limited.

• FDA approval · 2014-01-27
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for METOPROLOL SUCCINATE submitted by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2014-01-27
  FDA Approved: FUROSEMIDE — Original Application (Civica, Inc.)

  FDA approves Civica, Inc.’s original application for furosemide (generic diuretic).

• FDA approval · 2013-12-31
  FDA Approved: FOSINOPRIL SODIUM — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for fosinopril sodium from Chartwell RX, LLC, indicating approval of an ANDA supplemental submission…

• FDA approval · 2013-12-31
  FDA Approved: FOSINOPRIL SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for fosinopril sodium from Aurobindo Pharma Limited.

• CLINICAL_TRIALS approval · 2013-11-27
  Clinical Trial Update: Clinical Evaluation of Cardiac Resynchronization Therapy (CRT) Using the Ovatio CRT Implantable Cardioverter-defibrillator (ICD) System

  The Ovatio CRT Implantable Cardioverter-defibrillator System received marketing approval for use in congestive heart failure, according to t…

• FDA approval · 2013-10-29
  FDA Approved: LISINOPRIL — Original Application (Exelan Pharmaceuticals Inc.)

  FDA approved Exelan Pharmaceuticals’ Original Application for lisinopril, a generic ACE inhibitor, marking the availability of a generic lis…

• FDA approval · 2013-10-18
  FDA Approved: DIOVAN — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2013-09-10
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved Actavis's supplemental application for a generic lisinopril and hydrochlorothiazide tablet, expanding the approval to inclu…

• FDA approval · 2013-08-16
  FDA Approved: LISINOPRIL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901))

  FDA approved a supplemental application for generic lisinopril from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals), authorizing a cha…

• FDA approval · 2013-08-14
  FDA Approved: LISINOPRIL — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for lisinopril from Actavis Pharma, Inc., authorizing the marketing of a generic lisinopril product.