Heart Failure

• FDA approval · 2009-01-27
  FDA Approved: TORSEMIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' generic torsemide (Original Application), authorizing the generic torsemide tablet for edema associated…

• FDA approval · 2008-12-31
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental abbreviated new drug application for enalapril maleate from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals…

• FDA approval · 2008-12-23
  FDA Approved: ENALAPRILAT — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s original application for Enalaprilat (ENALAPRILAT), a generic ACE inhibitor, expanding ava…

• FDA approval · 2008-12-22
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for carvedilol submitted by Teva Pharmaceuticals USA, Inc. (carvedilol).

• FDA approval · 2008-12-19
  FDA Approved: COREG CR — Original Application (Waylis Therapeutics LLC)

  The FDA approves COREG CR (carvedilol phosphate) from Waylis Therapeutics LLC under an Original Application, introducing an extended-release…

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• FDA approval · 2008-12-19
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

  FDA approves Waylis Therapeutics LLC's supplemental application for COREG CR (carvedilol phosphate). This action updates the product under a…

• FDA approval · 2008-11-18
  FDA Approved: CARVEDILOL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for carvedilol from Quallent Pharmaceuticals Health LLC, authorizing a generic carvedilol tablet pro…

• FDA approval · 2008-10-22
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

  The FDA approved a supplemental application for LASIX (furosemide) from Validus Pharmaceuticals LLC.

• FDA approval · 2008-09-30
  FDA Approved: CARVEDILOL — Supplemental Application (UNICHEM PHARMACEUTICALS (USA), INC.)

  FDA approved a supplemental application for carvedilol from Unichem Pharmaceuticals (USA), Inc., expanding labeling for this product.

• FDA approval · 2008-09-12
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' Hydralazine Hydrochloride under an Original Application (ANDA).

• FDA approval · 2008-08-22
  FDA Approved: LISINOPRIL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901))

  FDA approved a supplemental application for lisinopril from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. to market a generi…

• FDA approval · 2008-08-22
  FDA Approved: BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Solco healthcare U.S., LLC)

  The FDA granted supplemental approval for a benazepril hydrochloride product (Solco Healthcare U.S., LLC), a generic ACE inhibitor used to m…

• FDA approval · 2008-08-22
  FDA Approved: CARVEDILOL — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for CARVEDILOL from Dr. Reddy's Laboratories Limited, authorizing its generic carvedilol product for…

• FDA approval · 2008-08-15
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (Exelan Pharmaceuticals Inc.)

  The FDA approved Exelan Pharmaceuticals Inc.'s original application for hydrochlorothiazide, a generic diuretic indicated for hypertension a…

• FDA approval · 2008-07-31
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for the lisinopril and hydrochlorothiazide combination from Actavis Pharma, Inc. The approval covers…

• FDA approval · 2008-06-20
  FDA Approved: RAMIPRIL — Original Application (GSMS, Incorporated)

  FDA approved RAMIPRIL as a generic drug under an original Abbreviated New Drug Application (ANDA 079116) filed by GSMS, Incorporated.

• FDA approval · 2008-06-18
  FDA Approved: RAMIPRIL — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s original ANDA for ramipril, authorizing the marketing of a generic ramipril product.

• FDA approval · 2008-06-18
  FDA Approved: RAMIPRIL — Original Application (Chartwell RX, LLC.)

  The FDA approved Chartwell RX, LLC's original generic application for ramipril, enabling the marketing of a RAMIPRIL product.

• FDA approval · 2008-05-09
  FDA Approved: TORSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for torsemide by Chartwell RX, LLC, updating an approved generic product (ANDA).

• FDA approval · 2008-05-01
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Leading Pharma, LLC)

  The FDA approved a supplemental application for hydrochlorothiazide submitted by Leading Pharma, LLC. This action updates the drug's labelin…

• FDA approval · 2008-04-30
  FDA Approved: BUMETANIDE — Original Application (Civica, Inc.)

  FDA approved Civica, Inc.'s original application for bumetanide, authorizing a generic version of the diuretic bumetanide.

• FDA approval · 2008-04-23
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for enalapril maleate (a generic ACE inhibitor) by Heritage Pharmaceuticals (d/b/a Avet Pharmace…

• FDA approval · 2008-04-10
  FDA Approved: TORSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's supplemental application for Torsemide, enabling the requested changes to the product's approval.

• FDA approval · 2008-02-27
  FDA Approved: MILRINONE LACTATE IN DEXTROSE — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved Baxter's supplemental application for milrinone lactate in dextrose under the ANDA pathway.

• FDA approval · 2008-02-15
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  FDA approved a supplemental NDA for TOPROL XL (metoprolol succinate) from Melinta Therapeutics, LLC, providing an additional or revised appr…