Cholestasis

• CLINICAL_TRIALS approval · 2025-08-19
  Clinical Trial Update: SMOF Lipid for Children With Parenteral Nutrition Induced Liver Injury

  SMOF Lipid has received marketing approval for use in pediatric patients with parenteral nutrition–induced liver injury, associated with cho…

• EMA approval · 2025-07-11
  EMA Authorised: Bylvay (odevixibat) — Ipsen Pharma

  EMA authorised Bylvay (odevixibat) from Ipsen Pharma for intrahepatic cholestasis as an orphan medicine with accelerated assessment.

• EMA approval · 2024-12-16
  EMA Authorised: Vedrop (tocofersolan) — Recordati Rare Diseases

  The EMA has authorised Vedrop (tocofersolan) for the treatment of cholestasis-associated vitamin E deficiency under the marketing authorisat…

• FDA approval · 2024-11-21
  FDA Approved: CHOLESTYRAMINE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved Macleods Pharmaceuticals' original application for cholestyramine, a bile acid sequestrant, for lowering cholesterol in hyperch…

• FDA approval · 2020-04-06
  FDA Approved: CHOLESTYRAMINE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA's original application for a generic cholestyramine product.

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• FDA approval · 2018-07-27
  FDA Approved: OMEGAVEN — Original Application (Fresenius Kabi USA, LLC)

  FDA approved OMEGAVEN, a fish oil-based parenteral lipid emulsion, under original NDA 210589 (Fresenius Kabi USA, LLC).

• 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 · 2013-07-26
  FDA Approved: QUESTRAN — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for QUESTRAN (cholestyramine) from Endo USA, Inc., updating its labeling to reflect additional indic…

• FDA approval · 2007-09-19
  FDA Approved: CHOLETEC — Supplemental Application (Bracco Diagnostics Inc)

  FDA approved a supplemental application for CHOLETEC (Mebrofenin) submitted by Bracco Diagnostics Inc. CHOLETEC is a radiopharmaceutical age…