Heart Failure

• FDA approval · 2011-01-06
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

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

• FDA approval · 2011-01-06
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

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

• FDA approval · 2010-12-27
  FDA Approved: RAMIPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for ramipril from Hikma Pharmaceuticals USA Inc., likely related to labeling or formulation changes …

• FDA approval · 2010-12-27
  FDA Approved: FUROSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for furosemide filed by Chartwell RX, LLC, authorizing changes under the supplemental NDA. The appro…

• FDA approval · 2010-12-03
  FDA Approved: MILRINONE LACTATE — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s original application for milrinone lactate injection, a generic milrinone, for the short-t…

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• FDA approval · 2010-11-29
  FDA Approved: TRANDOLAPRIL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for the generic drug trandolapril from Aurobindo Pharma Limited.

• FDA approval · 2010-11-01
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Hydralazine Hydrochloride (generic) from Teva Pharmaceuticals USA, Inc., authorizing the generic…

• FDA approval · 2010-11-01
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for hydralazine hydrochloride (Teva Pharmaceuticals USA, Inc.) under ANDA 089097, updating an alread…

• FDA approval · 2010-10-22
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for Losartan Potassium submitted by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2010-10-21
  FDA Approved: CARVEDILOL — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for carvedilol by Dr. Reddy's Laboratories Limited, enabling a new generic carvedilol product.

• FDA approval · 2010-10-18
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

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

• FDA approval · 2010-09-28
  FDA Approved: TORSEMIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for torsemide submitted by Chartwell RX, LLC under ANDA 076894. The action approves changes to t…

• FDA approval · 2010-09-17
  FDA Approved: QUINAPRIL — Supplemental Application (BluePoint Laboratories)

  FDA approves a supplemental application for Quinapril from BluePoint Laboratories, a generic ACE inhibitor.

• FDA approval · 2010-07-30
  FDA Approved: TRANDOLAPRIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for trandolapril, enabling the marketing of a generic formulation. This act…

• FDA approval · 2010-07-06
  FDA Approved: DIGOXIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Digoxin from Sun Pharmaceutical Industries, expanding/ updating the approved Digoxin product…

• FDA approval · 2010-07-02
  FDA Approved: SPIRONOLACTONE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original application for generic spironolactone, establishing a bioequivalent product to the refer…

• FDA approval · 2010-05-18
  FDA Approved: DIGOXIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Digoxin (Sandoz Inc), indicating an approved modification to this generic product's labeling/app…

• FDA approval · 2010-05-07
  FDA Approved: LISINOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' lisinopril supplemental application (ANDA 075903), making a generic lisinopril tablet available with ap…

• FDA approval · 2010-04-26
  FDA Approved: DIGOXIN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approves Amneal Pharmaceuticals of New York LLC's supplemental application for Digoxin (DIGOXIN), a generic product.

• FDA approval · 2010-03-30
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for carvedilol (generic), authorizing the continued marketing of a generic carvedilol product w…

• FDA approval · 2010-03-08
  FDA Approved: BUMETANIDE — Supplemental Application (Sagent Pharmaceuticals)

  The FDA approved a supplemental application for Bumetanide submitted by Sagent Pharmaceuticals.

• FDA approval · 2010-02-26
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved the original application for hydralazine hydrochloride, a generic antihypertensive. The approval covers a product manufactured …

• FDA approval · 2010-02-05
  FDA Approved: LANOXIN — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for Lanoxin (digoxin) from Covis Pharma US, Inc., resulting in updates to the product labeling under…

• FDA approval · 2010-02-04
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Hydralazine Hydrochloride submitted by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceutic…

• FDA approval · 2010-01-28
  FDA Approved: QUINAPRIL — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for Quinapril submitted by Cipla USA Inc. The approval confirms continued availability of Quinapril …