Malignant Hyperthermia

• FDA approval · 2025-04-18
  FDA Approved: DANTROLENE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for Dantrolene, confirming approval of its generic product for the tr…

• FDA approval · 2024-11-22
  FDA Approved: REVONTO — Supplemental Application (USWM, LLC)

  FDA approved a supplemental application for REVONTO (dantrolene sodium) from USWM, LLC under an ANDA.

• EMA approval · 2024-07-18
  EMA Authorised: Agilus (dantrolene sodium, hemiheptahydrate) — Norgine B.V.

  EMA authorised Agilus for malignant hyperthermia, with active substance dantrolene sodium hemiheptahydrate, manufactured by Norgine B.V.

• FDA approval · 2024-04-02
  FDA Approved: RYANODEX DANTROLENE SODIUM — Supplemental Application (Eagle Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Ryanodex Dantrolene Sodium (dantrolene sodium) submitted by Eagle Pharmaceuticals, Inc.

• FDA approval · 2024-04-02
  FDA Approved: DANTRIUM — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for DANTRIUM (dantrolene sodium) from Par Health USA, LLC.

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• FDA approval · 2015-10-01
  FDA Approved: RYANODEX DANTROLENE SODIUM — Supplemental Application (Eagle Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Ryanodex Dantrolene Sodium (dantrolene sodium) from Eagle Pharmaceuticals, Inc., indicating …

• FDA approval · 2015-08-31
  FDA Approved: DANTROLENE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for dantrolene sodium from Amneal Pharmaceuticals of New York LLC (ANDA076856), allowing continued m…

• FDA approval · 2014-07-22
  FDA Approved: RYANODEX DANTROLENE SODIUM — Original Application (Eagle Pharmaceuticals, Inc.)

  This FDA entry documents the original approval of Ryanodex Dantrolene Sodium (dantrolene sodium) by Eagle Pharmaceuticals, Inc. for the trea…

• FDA approval · 2014-03-11
  FDA Approved: DANTROLENE SODIUM — Supplemental Application (Endo USA, Inc.)

  The FDA approves a supplemental application for dantrolene sodium from Endo USA, Inc.

• FDA approval · 2012-07-17
  FDA Approved: DANTROLENE SODIUM — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for Dantrolene Sodium submitted by Endo USA, Inc.

• FDA approval · 2010-02-16
  FDA Approved: REVONTO — Supplemental Application (USWM, LLC)

  FDA approved a supplemental application for Revonto (dantrolene sodium) submitted by USWM, LLC.

• FDA approval · 2008-10-09
  FDA Approved: DANTRIUM — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for Dantrium (dantrolene sodium) from Par Health USA, LLC, under NDA 018264.