Cyanide Poisoning

• EMA approval · 2025-12-16
  EMA Authorised: Cyanokit (hydroxocobalamin) — SERB SA

  The EMA authorised Cyanokit (hydroxocobalamin) in the EU for the treatment of cyanide poisoning. SERB SA is the marketing authorisation hold…

• FDA approval · 2021-01-13
  FDA Approved: NITHIODOTE — Supplemental Application (Hope Pharmaceuticals)

  FDA approved a supplemental application for NITHIODOTE (sodium nitrite and sodium thiosulfate) from Hope Pharmaceuticals.

• FDA approval · 2018-12-31
  FDA Approved: CYANOKIT — Supplemental Application (BTG INTERNATIONAL INC.)

  The FDA approved a supplemental application for Cyanokit (hydroxocobalamin) submitted by BTG INTERNATIONAL INC.

• FDA approval · 2017-10-19
  FDA Approved: NITHIODOTE — Supplemental Application (Hope Pharmaceuticals)

  FDA approves a supplemental application for NITHIODOTE (sodium nitrite and sodium thiosulfate) from Hope Pharmaceuticals.

• FDA approval · 2017-10-19
  FDA Approved: SODIUM NITRITE — Supplemental Application (Hope Pharmaceuticals)

  FDA approved a supplemental application for sodium nitrite submitted by Hope Pharmaceuticals. The approval updates the NDA for this product.

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• FDA approval · 2016-06-14
  FDA Approved: NITHIODOTE — Supplemental Application (Hope Pharmaceuticals)

  FDA approved a supplemental application for NITHIODOTE, the combination of sodium nitrite and sodium thiosulfate, from Hope Pharmaceuticals.

• FDA approval · 2016-04-22
  FDA Approved: NITHIODOTE — Supplemental Application (Hope Pharmaceuticals)

  FDA approves a supplemental application for NITHIODOTE (sodium nitrite and sodium thiosulfate) from Hope Pharmaceuticals.

• FDA approval · 2015-02-03
  FDA Approved: NITHIODOTE — Supplemental Application (Hope Pharmaceuticals)

  The FDA approved Hope Pharmaceuticals' supplemental application for NITHIODOTE, a combination of sodium nitrite and sodium thiosulfate, to s…

• FDA approval · 2015-01-26
  FDA Approved: NITHIODOTE — Supplemental Application (Hope Pharmaceuticals)

  The FDA approved a supplemental application for NITHIODOTE, a cyanide antidote containing sodium nitrite and sodium thiosulfate, submitted b…

• FDA approval · 2014-11-24
  FDA Approved: NITHIODOTE — Supplemental Application (Hope Pharmaceuticals)

  FDA approved a supplemental application for NITHIODOTE (sodium nitrite and sodium thiosulfate) from Hope Pharmaceuticals. The approval cover…

• FDA approval · 2014-07-03
  FDA Approved: CYANOKIT — Supplemental Application (BTG INTERNATIONAL INC.)

  The FDA approved a supplemental application for Cyanokit (hydroxocobalamin) submitted by BTG International Inc. for use related to cyanide p…

• FDA approval · 2014-06-03
  FDA Approved: NITHIODOTE — Supplemental Application (Hope Pharmaceuticals)

  FDA approved a supplemental application for NITHIODOTE, a combination of sodium nitrite and sodium thiosulfate, from Hope Pharmaceuticals.

• FDA approval · 2013-11-21
  FDA Approved: CYANOKIT — Supplemental Application (BTG INTERNATIONAL INC.)

  FDA approved a supplemental application for Cyanokit (hydroxocobalamin) submitted by BTG International Inc., updating regulatory information…

• FDA approval · 2013-11-14
  FDA Approved: NITHIODOTE — Supplemental Application (Hope Pharmaceuticals)

  FDA approves a supplemental NDA for NITHIODOTE (sodium nitrite and sodium thiosulfate) from Hope Pharmaceuticals.

• FDA approval · 2013-04-08
  FDA Approved: NITHIODOTE — Supplemental Application (Hope Pharmaceuticals)

  The FDA approved a supplemental application for NITHIODOTE (sodium nitrite and sodium thiosulfate) from Hope Pharmaceuticals. The approval p…

• FDA approval · 2013-03-28
  FDA Approved: NITHIODOTE — Supplemental Application (Hope Pharmaceuticals)

  FDA approved Hope Pharmaceuticals' supplemental application for NITHIODOTE (sodium nitrite and sodium thiosulfate), expanding its labeling f…

• FDA approval · 2012-02-14
  FDA Approved: SODIUM NITRITE — Original Application (Hope Pharmaceuticals)

  FDA has approved an Original Application for Sodium nitrite from Hope Pharmaceuticals for the treatment of cyanide poisoning.

• FDA approval · 2011-04-08
  FDA Approved: CYANOKIT — Supplemental Application (BTG INTERNATIONAL INC.)

  FDA approved a supplemental application for Cyanokit (hydroxocobalamin) filed by BTG International Inc., expanding its regulatory approval.

• FDA approval · 2011-01-14
  FDA Approved: NITHIODOTE — Original Application (Hope Pharmaceuticals)

  FDA approved NITHIODOTE, a combination of sodium nitrite and sodium thiosulfate, under an Original Application by Hope Pharmaceuticals as an…

• FDA approval · 2010-10-13
  FDA Approved: CYANOKIT — Supplemental Application (BTG INTERNATIONAL INC.)

  FDA approved a supplemental application for CYANOKIT (HYDROXOCOBALAMIN) from BTG INTERNATIONAL INC.

• FDA approval · 2010-02-19
  FDA Approved: CYANOKIT — Supplemental Application (BTG INTERNATIONAL INC.)

  FDA approved a supplemental application for Cyanokit (hydroxocobalamin) from BTG International Inc.

• FDA approval · 2009-06-04
  FDA Approved: CYANOKIT — Supplemental Application (BTG INTERNATIONAL INC.)

  The FDA approved a supplemental application for Cyanokit (hydroxocobalamin) from BTG International Inc., representing an update to its label…

• FDA approval · 2006-12-15
  FDA Approved: CYANOKIT — Original Application (BTG INTERNATIONAL INC.)

  FDA approved Cyanokit (hydroxocobalamin) from BTG INTERNATIONAL INC. as an original NDA (NDA022041) for the treatment of cyanide poisoning.