Heart Failure

• FDA approval · 2015-02-23
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Digoxin submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2015-02-06
  FDA Approved: ATACAND — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for ATACAND (candesartan cilexetil) submitted by ANI Pharmaceuticals, Inc.

• FDA approval · 2015-01-20
  FDA Approved: CAPTOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA granted a supplemental approval for CAPTOPRIL (captopril) from Camber Pharmaceuticals, Inc., updating the labeling for an existing capto…

• FDA approval · 2015-01-05
  FDA Approved: VALSARTAN — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved an Abbreviated New Drug Application for valsartan by Mylan Pharmaceuticals, enabling a generic version of the drug.

• FDA approval · 2015-01-05
  FDA Approved: VALSARTAN — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for valsartan, a generic ARB. The product is indicated for hypertension, heart fai…

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• FDA approval · 2015-01-05
  FDA Approved: VALSARTAN — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original application for valsartan, a generic ARB, for hypertension, heart failure, and reducing cardiov…

• FDA approval · 2015-01-05
  FDA Approved: VALSARTAN — Original Application (Aurobindo Pharma Limited)

  FDA approves the Original Application for VALSARTAN from Aurobindo Pharma Limited, enabling the generic valsartan product to enter the marke…

• FDA approval · 2015-01-05
  FDA Approved: VALSARTAN — Original Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved Jubilant Cadista Pharmacuticals Inc.'s original ANDA for valsartan, a generic angiotensin II receptor blocker. The approval ena…

• FDA approval · 2014-12-24
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (OCEANSIDE PHARMACEUTICALS)

  FDA approved a supplemental application for Enalapril Maleate by Oceanside Pharmaceuticals under NDA 018998. The approval updates the produc…

• FDA approval · 2014-12-19
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC under the ANDA. The action approves changes to the al…

• FDA approval · 2014-12-11
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  FDA approved a supplemental application for lisinopril filed by Solco Healthcare U.S., LLC.

• FDA approval · 2014-12-05
  FDA Approved: CAPTOPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for captopril from Hikma Pharmaceuticals USA, documenting changes to the marketed captopril product …

• FDA approval · 2014-11-26
  FDA Approved: CARVEDILOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's supplemental application for carvedilol, enabling a generic carvedilol product to be marketed.

• FDA approval · 2014-11-04
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA has granted supplemental approval for Losartan Potassium from Macleods Pharmaceuticals Limited. This action approves the supplementa…

• FDA approval · 2014-11-03
  FDA Approved: CAPTOPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA's supplemental application for captopril (CAPTOPRIL), enabling the generic captopril product under th…

• FDA approval · 2014-10-31
  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 · 2014-10-22
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for a generic spironolactone and hydrochlorothiazide combination product from Prasco Laboratories.

• FDA approval · 2014-10-20
  FDA Approved: BUMETANIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for bumetanide from Sandoz Inc.

• FDA approval · 2014-09-26
  FDA Approved: RAMIPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for RAMIPRIL from Hikma Pharmaceuticals USA Inc. under ANDA077900.

• FDA approval · 2014-09-26
  FDA Approved: RAMIPRIL — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for RAMIPRIL (ramipril) from Zydus Lifesciences Limited.

• FDA approval · 2014-09-26
  FDA Approved: QUINAPRIL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Quinapril hydrochloride by Aurobindo Pharma Limited.

• FDA approval · 2014-09-25
  FDA Approved: QUINAPRIL — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for Quinapril from Chartwell RX, LLC, authorizing a generic quinapril product under an ANDA.

• FDA approval · 2014-09-25
  FDA Approved: CARVEDILOL — Supplemental Application (Advagen Pharma Ltd)

  The FDA approved Advagen Pharma Ltd's supplemental application for carvedilol (generic). This is an approval of a supplemental filing for a …

• FDA approval · 2014-09-24
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for a generic spironolactone and hydrochlorothiazide combination product from Sun Pharmaceutical Ind…

• FDA approval · 2014-09-22
  FDA Approved: CARVEDILOL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for carvedilol by Aurobindo Pharma Limited. This represents approval of a generic carvedilol pro…