Hepatic Cirrhosis

• FDA approval · 2019-09-06
  FDA Approved: ETHACRYNIC ACID — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals, Inc.'s Original Application for Ethacrynic acid, authorizing a generic version of the loop diuretic. Thi…

• FDA approval · 2019-08-27
  FDA Approved: ETHACRYNIC ACID — Original Application (ScieGen Pharmaceuticals Inc)

  FDA approved Ethacrynic acid from ScieGen Pharmaceuticals Inc under an Original Application (ANDA211232).

• FDA approval · 2019-08-05
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's supplemental application for spironolactone, enabling the marketing of a new generic product.

• FDA approval · 2019-07-25
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for spironolactone submitted by Sun Pharmaceutical Industries, Inc., indicating an update to the…

• FDA approval · 2019-05-03
  FDA Approved: FUROSEMIDE — Original Application (Eugia US LLC)

  FDA approved an original ANDA for FUROSEMIDE by Eugia US LLC, confirming a generic version of the diuretic. This is a routine generic drug a…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2019-04-24
  FDA Approved: BUMETANIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for Bumetanide from Upsher-Smith Laboratories, LLC.

• FDA approval · 2019-02-26
  FDA Approved: CHLORTHALIDONE — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's original application for chlorthalidone, a generic diuretic. This enables marketing of the generic chlo…

• FDA approval · 2018-10-12
  FDA Approved: CHLORTHALIDONE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved Dr. Reddy's Laboratories Inc.'s original application for chlorthalidone (generic diuretic) under ANDA210742.

• FDA approval · 2018-05-08
  FDA Approved: ETHACRYNIC ACID — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the original generic application for Ethacrynic acid from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2018-01-23
  FDA Approved: BUMETANIDE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Bumetanide under an Original Application for Upsher-Smith Laboratories, establishing a generic version of the loop diuretic.

• FDA approval · 2017-07-14
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide submitted by Hikma Pharmaceuticals USA Inc. The notice confirms regulatory approval o…

• CLINICAL_TRIALS research · 2017-06-28
  Clinical Trial Update: Prevalence of Osteoporosis and Fractures in Patients With Hepatic Cirrhosis and Investigation of the Associated Factors

  This clinical trial update examines how common osteoporosis and bone fractures are in patients with hepatic cirrhosis and explores factors a…

• FDA approval · 2017-03-30
  FDA Approved: CHLORTHALIDONE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved an original application for chlorthalidone from Rising Pharma Holdings, Inc., a generic diuretic indicated for hypertension and…

• FDA approval · 2016-09-22
  FDA Approved: FUROSEMIDE — Supplemental Application (Hospira, Inc.)

  FDA approves Hospira, Inc.'s supplemental application for furosemide, initiating a supplemental approval for the drug. The action updates th…

• FDA approval · 2016-07-20
  FDA Approved: FUROSEMIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original application for furosemide, authorizing a generic version of this diuretic.

• CLINICAL_TRIALS trial_result · 2016-05-23
  Clinical Trial Update: Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis [Phase 1]

  Phase 1 trial evaluating human umbilical cord-derived mesenchymal stem cells for hepatic cirrhosis; trial status is currently unknown.

• FDA approval · 2016-03-04
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for LASIX (furosemide) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2015-09-28
  FDA Approved: BUMEX — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for Bumex (bumetanide) filed by Validus Pharmaceuticals LLC.

• FDA approval · 2015-08-07
  FDA Approved: FUROSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for furosemide submitted by Chartwell RX, LLC.

• FDA label_change · 2015-03-30
  FDA Approved: EDECRIN — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for EDECRIN (ethacrynic acid) submitted by Bausch Health US, LLC, updating the drug's labeling.

• 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.

• CLINICAL_TRIALS trial_result · 2014-08-20
  Clinical Trial Update: Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy [NA]

  This clinical trial update reports completion of a study evaluating a hyperproteic diet combined with Lactobacillus reuteri and nitazoxanide…

• FDA approval · 2012-12-12
  FDA Approved: TORSEMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for torsemide from Teva Pharmaceuticals USA, Inc., updating or expanding the product's labeling.

• CLINICAL_TRIALS trial_result · 2012-10-12
  Clinical Trial Update: Dose Exploring and Setting Study for Tolvaptan to Treat Hepatic Cirrhosis With Ascites [Phase 2]

  Phase 2 dose-exploration study of tolvaptan for hepatic cirrhosis with ascites has completed.