Osteosarcoma

• EMA approval · 2025-12-18
  EMA Authorised: Mepact (mifamurtide) — Esteve Pharmaceuticals, S.A.

  The European Medicines Agency authorised Mepact (mifamurtide) for the treatment of osteosarcoma; the marketing authorization holder is Estev…

• FDA approval · 2024-10-23
  FDA Approved: JYLAMVO — Supplemental Application (SHORLA ONCOLOGY INC.)

  The FDA approved a supplemental application for JYLAMVO (methotrexate) filed by SHORLA ONCOLOGY INC.

• FDA approval · 2024-06-03
  FDA Approved: METHOTREXATE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' original application for methotrexate, authorizing the generic version of the drug.

• FDA approval · 2022-11-29
  FDA Approved: JYLAMVO — Original Application (SHORLA ONCOLOGY INC.)

  FDA approved JYLAMVO (methotrexate) under an Original Application from SHORLA ONCOLOGY INC.

• FDA approval · 2021-10-25
  FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Methotrexate by Hikma Pharmaceuticals USA Inc. (ANDA089342).

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• FDA approval · 2021-10-25
  FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves a supplemental application for Methotrexate by Hikma Pharmaceuticals USA Inc., enabling a new generic version of the drug.

• FDA approval · 2021-06-14
  FDA Approved: TREXALL — Supplemental Application (Teva Women's Health, Inc.)

  The FDA approved a supplemental application for TREXALL (methotrexate) filed by Teva Women's Health, Inc.

• FDA approval · 2020-10-13
  FDA Approved: LEUCOVORIN CALCIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Leucovorin Calcium by Hikma Pharmaceuticals USA Inc., resulting in updated labeling for the gene…

• FDA approval · 2020-01-30
  FDA Approved: METHOTREXATE — Original Application (Chartwell RX, LLC)

  FDA approvedChartwell RX, LLC's methotrexate product under an Original Application, making a new generic version of methotrexate available. …

• FDA approval · 2019-08-22
  FDA Approved: LEVOLEUCOVORIN — Original Application (Meitheal Pharmaceuticals Inc)

  FDA approved Meitheal Pharmaceuticals' levoleucovorin calcium as an original application (ANDA) for a generic product.

• FDA approval · 2018-07-27
  FDA Approved: LEUCOVORIN CALCIUM — Original Application (Fresenius Kabi USA, LLC)

  FDA approved a generic Leucovorin Calcium under ANDA 207226 for Fresenius Kabi USA, LLC.

• FDA approval · 2018-03-15
  FDA Approved: METHOTREXATE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Methotrexate submitted by Hospira, Inc.

• FDA approval · 2017-03-07
  FDA Approved: METHOTREXATE — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for METHOTREXATE SODIUM from Fresenius Kabi USA, LLC.

• FDA approval · 2016-12-20
  FDA Approved: TREXALL — Supplemental Application (Teva Women's Health, Inc.)

  FDA approved a supplemental application for TREXALL (methotrexate) from Teva Women's Health, Inc.

• FDA approval · 2016-06-16
  FDA Approved: LEVOLEUCOVORIN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s levoleucovorin as an Original Application generic; levoleucovorin is used in cancer regimens w…

• FDA approval · 2011-04-25
  FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for METHOTREXATE from Hikma Pharmaceuticals USA Inc., granting a supplemental approval for the g…

• FDA approval · 2007-04-30
  FDA Approved: METHOTREXATE — Original Application (Accord Healthcare, Inc.)

  The FDA approved Accord Healthcare's original application for Methotrexate (generic).