Hemorrhagic Cystitis

• FDA approval · 2025-01-13
  FDA Approved: MESNA — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved the original application for MESNA (Ingenus Pharmaceuticals, LLC) to reduce the risk of chemotherapy-related hemorrhagic cystit…

• FDA approval · 2024-07-17
  FDA Approved: MESNA — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for MESNA submitted by Hikma Pharmaceuticals USA Inc., likely expanding or updating its labeling.

• FDA approval · 2019-09-15
  FDA Approved: MESNA — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for MESNA submitted by Fresenius Kabi USA, LLC.

• FDA approval · 2019-09-06
  FDA Approved: MESNA — Supplemental Application (Gland Pharma Limited)

  FDA approved a supplemental application for MESNA Injection from Gland Pharma Limited, validating its manufacture and labeling for this gene…

• FDA approval · 2018-12-17
  FDA Approved: MESNA — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for MESNA submitted by Baxter Healthcare Company. This approval updates the approval status of MESNA…

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• FDA approval · 2018-12-17
  FDA Approved: MESNEX — Supplemental Application (Baxter Healthcare Company)

  The FDA approved a supplemental application for MESNEX (mesna) from Baxter Healthcare Company. The action relates to the approved use of MES…

• FDA approval · 2017-12-18
  FDA Approved: MESNA — Original Application (Gland Pharma Limited)

  FDA approved an Original Application for MESNA injection from Gland Pharma Limited. MESNA is used to prevent chemotherapy-induced hemorrhagi…

• FDA approval · 2016-02-26
  FDA Approved: MESNA — Supplemental Application (Baxter Healthcare Company)

  The FDA approved a supplemental application for MESNA submitted by Baxter Healthcare Company. The action updates MESNA's labeling under the …

• FDA approval · 2015-11-18
  FDA Approved: MESNA — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for MESNA submitted by Fresenius Kabi USA, LLC (ANDA 075811). This approval updates the regulato…

• FDA approval · 2015-08-21
  FDA Approved: MESNA — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for MESNA submitted by Sagent Pharmaceuticals, resulting in an approved change to the product’s labe…

• FDA approval · 2014-03-17
  FDA Approved: MESNEX — Supplemental Application (Baxter Healthcare Company)

  FDA approved a supplemental application for MESNEX (mesna) submitted by Baxter Healthcare Company.

• FDA approval · 2014-03-17
  FDA Approved: MESNA — Supplemental Application (Baxter Healthcare Company)

  The FDA approved a supplemental application for MESNA by Baxter Healthcare Company.

• FDA approval · 2012-12-28
  FDA Approved: MESNEX — Supplemental Application (Baxter Healthcare Company)

  The FDA approved a supplemental application for MESNEX (mesna) from Baxter Healthcare Company.

• FDA approval · 2010-04-13
  FDA Approved: MESNA — Original Application (Sagent Pharmaceuticals)

  FDA approved MESNA (Sagent Pharmaceuticals) through an Original Application/ANDA to protect against chemotherapy-induced hemorrhagic cystiti…