Liver Disease

• FDA approval · 2025-07-24
  FDA Approved: DOPTELET SPRINKLE — Original Application (AkaRx, Inc.)

  FDA approved the original application for DOPTELET SPRINKLE (avatrombopag) from AkaRx, Inc.

• FDA approval · 2025-07-24
  FDA Approved: DOPTELET — Supplemental Application (AkaRx, Inc.)

  FDA approved a supplemental application for DOPTELET (avatrombopag) by AkaRx, Inc.

• FDA approval · 2021-10-14
  FDA Approved: DOPTELET — Supplemental Application (AkaRx, Inc.)

  FDA approved a supplemental application for DOPTELET (avatrombopag maleate) from AkaRx, Inc., likely to modify the label or add/expand an in…

• FDA approval · 2020-08-20
  FDA Approved: DOPTELET — Supplemental Application (AkaRx, Inc.)

  FDA approved a supplemental application for DOPTELET (avatrombopag maleate) from AkaRx, Inc., likely expanding labeling or indications.

• CLINICAL_TRIALS approval · 2019-02-12
  Clinical Trial Update: Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury

  IV fish oil for parenteral nutrition–associated liver injury has been approved for marketing, marking regulatory clearance for this therapy …

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2018-07-31
  FDA Approved: MULPLETA — Original Application (Eddingpharm (U. S. ) Inc.)

  The FDA granted original approval for Mulpleta (lusutrombopag) for adults with chronic liver disease to raise platelet counts in advance of …

• FDA approval · 2018-05-21
  FDA Approved: DOPTELET — Original Application (AkaRx, Inc.)

  FDA approved DOPTELET (avatrombopag) from AkaRx, Inc. for reducing the need for platelet transfusions in adults with chronic liver disease u…

• FDA approval · 2015-09-10
  FDA Approved: CHOLETEC — Supplemental Application (Bracco Diagnostics Inc)

  FDA approved a supplemental application for CHOLETEC (mebrofenin) submitted by Bracco Diagnostics Inc. This entry notes the supplemental app…

• FDA approval · 2011-11-16
  FDA Approved: EOVIST — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approves a supplemental application for EOVIST (gadoxetate disodium) from Bayer HealthCare Pharmaceuticals Inc. for its liver-imaging in…

• FDA approval · 2010-08-12
  FDA Approved: KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for a kit to prepare Technetium-99m mebrofenin for hepatobiliary imaging, manufactured by Sun Pharma…

• FDA approval · 2008-07-03
  FDA Approved: EOVIST — Original Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved EOVIST (gadoxetate disodium) through an original NDA for use as an MRI contrast agent to enhance liver imaging and help detect …