Cirrhosis

• EMA approval · 2025-11-10
  EMA Authorised: Rezdiffra (resmetirom) — Madrigal Pharmaceuticals EU Limited

  EMA authorised Rezdiffra (resmetirom) for non-alcoholic fatty liver disease and cirrhosis of the liver, granted with conditional approval.

• FDA approval · 2025-01-28
  FDA Approved: INZIRQO — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved INZIRQO, a brand-name hydrochlorothiazide, under ANI Pharmaceuticals' original application.

• FDA approval · 2024-09-19
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for hydrochlorothiazide from Teva Pharmaceuticals USA, Inc. The approval concerns regulatory changes…

• FDA approval · 2024-04-30
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Accord Healthcare Inc.)

  The FDA approved a supplemental application for hydrochlorothiazide filed by Accord Healthcare Inc. under ANDA 202556. The document does not…

• FDA approval · 2023-07-21
  FDA Approved: TORSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for torsemide, granting approval of a generic torsemide product u…

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• FDA approval · 2022-12-19
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  FDA approves a supplemental application for the combination product spironolactone and hydrochlorothiazide, manufactured by Prasco Laborator…

• 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 · 2021-02-26
  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 · 2018-04-23
  FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

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

• FDA approval · 2016-03-08
  FDA Approved: FUROSEMIDE — Supplemental Application (Phlow Corporation)

  FDA approved a supplemental application for furosemide submitted by Phlow Corporation.

• FDA approval · 2015-04-26
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Spironolactone from Mylan Pharmaceuticals Inc., indicating an approved change to an already-appr…

• 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 · 2012-05-10
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

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

• FDA approval · 2012-05-09
  FDA Approved: FUROSEMIDE — Supplemental Application (Solco Healthcare LLC)

  FDA approved a supplemental application for furosemide from Solco Healthcare LLC, authorizing continued production and marketing of the gene…

• FDA approval · 2009-05-19
  FDA Approved: SAMSCA — Original Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved Samsca (tolvaptan) from Otsuka America for the treatment of clinically significant hyponatremia in adults, including hyponatrem…

• 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 · 2007-06-29
  FDA Approved: FUROSEMIDE — Supplemental Application (Leading Pharma, LLC)

  FDA approves a supplemental application for furosemide submitted by Leading Pharma, LLC.