Adrenal Insufficiency

• EMA approval · 2026-07-02
  EMA Authorised: Alkindi (hydrocortisone) — Immedica Pharma AB

  EMA authorises Alkindi (hydrocortisone) for adrenal insufficiency, expanding treatment options.

• EMA approval · 2026-03-10
  EMA Authorised: Alkindi (hydrocortisone) — Immedica Netherlands B.V.

  The EMA authorised Alkindi (hydrocortisone) by Immedica Netherlands B.V. for adrenal insufficiency.

• FDA approval · 2025-05-28
  FDA Approved: KHINDIVI — Original Application (Eton Pharmaceuticals, Inc.)

  FDA approved KHINDIVI (hydrocortisone) through an original NDA submitted by Eton Pharmaceuticals, Inc.

• FDA approval · 2024-11-25
  FDA Approved: HYDROCORTISONE — Original Application (Eywa Pharma Inc)

  FDA approved HYDROCORTISONE from Eywa Pharma Inc under an Original Application (ANDA 217160). This entry documents the approval of a generic…

• FDA approval · 2024-01-05
  FDA Approved: DEXAMETHASONE INTENSOL — Supplemental Application (Hikma Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for DEXAMETHASONE INTENSOL from Hikma Pharmaceuticals USA, Inc., a dexamethasone product.

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• FDA approval · 2023-12-22
  FDA Approved: CORTROSYN — Supplemental Application (Amphastar Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Cortrosyn (cosyntropin) from Amphastar Pharmaceuticals, Inc., authorizing changes to the app…

• EMA approval · 2023-10-13
  EMA Authorised: Plenadren (hydrocortisone) — Takeda Pharmaceuticals International AG Ireland Branch

  The EMA authorised Plenadren (hydrocortisone) for adrenal insufficiency, indicating regulatory approval and listing Takeda as the Marketing …

• FDA approval · 2022-12-23
  FDA Approved: ALKINDI SPRINKLE — Supplemental Application (Eton Pharmaceuticals, Inc.)

  FDA approved a supplemental application for ALKINDI SPRINKLE (hydrocortisone) from Eton Pharmaceuticals. The approval updates its labeling a…

• FDA approval · 2022-05-31
  FDA Approved: FLUDROCORTISONE ACETATE — Original Application (Novitium Pharma LLC)

  FDA approved the original generic application for fludrocortisone acetate (ANDA 215279) from Novitium Pharma LLC. This approval makes a gene…

• FDA approval · 2022-02-03
  FDA Approved: ALKINDI SPRINKLE — Supplemental Application (Eton Pharmaceuticals, Inc.)

  FDA approved a supplemental application for ALKINDI SPRINKLE (hydrocortisone) from Eton Pharmaceuticals. The action represents an approval o…

• FDA approval · 2021-12-14
  FDA Approved: CORTROSYN — Supplemental Application (Amphastar Pharmaceuticals, Inc.)

  The FDA approved Amphastar Pharmaceuticals' supplemental application for Cortrosyn (cosyntropin), a diagnostic agent used to assess adrenal …

• FDA approval · 2020-09-29
  FDA Approved: ALKINDI SPRINKLE — Original Application (Eton Pharmaceuticals, Inc.)

  FDA approves ALKINDI SPRINKLE (hydrocortisone granules) from an original NDA by Eton Pharmaceuticals, providing hydrocortisone replacement t…

• FDA approval · 2020-09-02
  FDA Approved: PREDNISONE — Original Application (Strides Pharma Science Limited)

  FDA approval of a generic prednisone (PREDNISONE) Original Application by Strides Pharma Science Limited.

• FDA approval · 2012-06-29
  FDA Approved: COSYNTROPIN — Original Application (Sandoz Inc)

  FDA approves a generic cosyntropin injection (Cosyntropin) under an Original Application by Sandoz Inc.

• FDA approval · 2007-11-28
  FDA Approved: HYDROCORTISONE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for Hydrocortisone by Padagis Israel Pharmaceuticals Ltd, indicating an update to the product's appr…