Adrenocortical Carcinoma

• EMA approval · 2026-03-11
  EMA Authorised: Lysodren (mitotane) — Esteve Pharmaceuticals, S.A.

  EMA authorised marketing of Lysodren (mitotane) by Esteve Pharmaceuticals, S.A. for adrenal cortex neoplasms.

• FDA approval · 2024-10-28
  FDA Approved: LYSODREN — Supplemental Application (ESTEVE PHARMACEUTICALS, S.A.)

  The FDA approved a supplemental application for LYSODREN (mitotane) submitted by Esteve Pharmaceuticals, S.A.

• FDA approval · 2021-06-15
  FDA Approved: LYSODREN — Supplemental Application (ESTEVE PHARMACEUTICALS, S.A.)

  The FDA approved a supplemental application for LYSODREN (mitotane) submitted by Esteve Pharmaceuticals, S.A., resulting in approval of a re…

• FDA approval · 2017-05-09
  FDA Approved: LYSODREN — Supplemental Application (ESTEVE PHARMACEUTICALS, S.A.)

  The FDA approved a supplemental application for LYSODREN (mitotane) filed by ESTEVE Pharmaceuticals, S.A.

• FDA approval · 2013-11-15
  FDA Approved: LYSODREN — Supplemental Application (ESTEVE PHARMACEUTICALS, S.A.)

  FDA approved a supplemental application for LYSODREN (mitotane) from Esteve Pharmaceuticals, S.A., related to its labeling/indication.

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• FDA approval · 2009-02-10
  FDA Approved: LYSODREN — Supplemental Application (ESTEVE PHARMACEUTICALS, S.A.)

  FDA approved a supplemental application for LYSODREN (mitotane) filed by ESTEVE PHARMACEUTICALS, S.A.