Hepatocellular Carcinoma

• FDA label_change · 2021-12-28
  FDA Approved: EOVIST — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for EOVIST (gadoxetate disodium) to update the product labeling.

• FDA label_change · 2017-04-27
  FDA Approved: STIVARGA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA page documents Bayer's supplemental application for Stivarga (regorafenib), indicating a label change is being sought.

• FDA label_change · 2015-03-27
  FDA Approved: EOVIST — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA notes Bayer's supplemental application for EOVIST (gadoxetate disodium) to modify the drug's labeling.

• FDA label_change · 2010-12-20
  FDA Approved: MULTIHANCE — Supplemental Application (BRACCO DIAGNOSTICS INC)

  The FDA approved a supplemental application for MULTIHANCE (gadobenate dimeglumine) to update its labeling and imaging indications.