Malignant Pleural Mesothelioma

• FDA approval · 2025-10-09
  FDA Approved: PEMETREXED — Supplemental Application (Waverley Pharma Inc)

  FDA approved a supplemental application for pemetrexed disodium by Waverley Pharma Inc, resulting in updated approval/label for the generic …

• FDA approval · 2025-08-06
  FDA Approved: PEMETREXED — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for pemetrexed by Accord Healthcare Inc., enabling the generic version to be marketed under approved…

• FDA approval · 2025-06-18
  FDA Approved: AXTLE — Supplemental Application (Avyxa Pharma, LLC)

  FDA approved a supplemental application for AXTLE (pemetrexed) submitted by Avyxa Pharma, LLC.

• FDA approval · 2024-11-15
  FDA Approved: PEMRYDI RTU — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for PEMRYDI RTU, a ready-to-use formulation of pemetrexed disodium, developed by Amneal Pharmace…

• FDA approval · 2024-06-28
  FDA Approved: AXTLE — Original Application (Avyxa Pharma, LLC)

  FDA approved the original application for AXTLE (pemetrexed) by Avyxa Pharma, LLC, for treatment of malignant pleural mesothelioma and non-s…

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• FDA approval · 2024-06-14
  FDA Approved: PEMETREXED — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for a generic pemetrexed disodium, enabling manufacturing and marketing of this ge…

• FDA approval · 2024-02-29
  FDA Approved: PEMETREXED — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for a generic pemetrexed disodium product from BluePoint Laboratories.

• FDA approval · 2024-02-29
  FDA Approved: PEMETREXED — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for pemetrexed disodium (Pemetrexed) submitted by BluePoint Laboratories.

• FDA approval · 2023-12-11
  FDA Approved: PEMETREXED — Original Application (Solco Healthcare US, LLC)

  FDA approved the original generic application for pemetrexed (PEMETREXED) by Solco Healthcare US, LLC.

• FDA approval · 2023-09-25
  FDA Approved: PEMETREXED — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for pemetrexed disodium (pemetrexed) submitted by Fresenius Kabi USA, LLC.

• FDA approval · 2023-08-29
  FDA Approved: PEMETREXED DISODIUM — Supplemental Application (Dr. Reddys Laboratories Inc)

  FDA approved a supplemental application for pemetrexed disodium submitted by Dr. Reddy's Laboratories Inc.

• FDA approval · 2023-08-29
  FDA Approved: PEMETREXED — Supplemental Application (Accord Healthcare Inc.)

  The FDA has approved Accord Healthcare Inc.'s supplemental application for pemetrexed (PEMETREXED), related to the approved pemetrexed produ…

• FDA approval · 2023-07-12
  FDA Approved: PEMETREXED — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for pemetrexed submitted by BluePoint Laboratories. This action approves the generic pemetrexed …

• FDA approval · 2023-06-14
  FDA Approved: IMJUDO — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for IMJUDO (tremelimumab) from AstraZeneca.

• FDA approval · 2023-05-22
  FDA Approved: PEMRYDI RTU — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved PEMRYDI RTU (pemetrexed disodium) from Amneal Pharmaceuticals as an Original Application, providing a ready-to-use formulation …

• FDA approval · 2023-04-21
  FDA Approved: PEMETREXED — Supplemental Application (Sandoz Inc.)

  The FDA approved a supplemental application for pemetrexed disodium, enabling the generic pemetrexed product from Sandoz Inc. to be marketed…

• FDA approval · 2023-02-27
  FDA Approved: PEMETREXED — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for pemetrexed disodium from Sagent Pharmaceuticals, enabling continued availability of this generic…

• FDA approval · 2022-12-14
  FDA Approved: PEMFEXY — Supplemental Application (Eagle Pharmaceuticals, Inc.)

  FDA approved a supplemental application for PEMFEXY (pemetrexed) from Eagle Pharmaceuticals.

• FDA approval · 2022-12-13
  FDA Approved: PEMETREXED — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved the original application for pemetrexed disodium from Meitheal Pharmaceuticals Inc., a generic version of the cancer drug pemet…

• FDA approval · 2022-11-22
  FDA Approved: PEMETREXED — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved a supplemental application for pemetrexed filed by Teva Pharmaceuticals, Inc., expanding the drug's labeled uses.

• FDA approval · 2022-06-22
  FDA Approved: PEMETREXED — Original Application (Hospira, Inc.)

  FDA approved Hospira, Inc.'s original application for pemetrexed (injectable), authorizing a generic pemetrexed product with the established…

• FDA approval · 2022-05-25
  FDA Approved: PEMETREXED — Original Application (Zydus Lifesciences Limited)

  The FDA approved a generic pemetrexed disodium product (PEMETREXED DISODIUM) from Zydus Lifesciences Limited.

• FDA approval · 2022-05-25
  FDA Approved: PEMETREXED DISODIUM — Original Application (Dr. Reddys Laboratories Inc)

  FDA approval of a generic pemetrexed disodium product (ANDA) submitted by Dr. Reddy's Laboratories Inc.

• FDA approval · 2022-05-25
  FDA Approved: PEMETREXED — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s original application for a generic pemetrexed product.

• FDA approval · 2022-05-25
  FDA Approved: PEMETREXED — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals' original application for pemetrexed disodium, a generic version of pemetrexed for cancer indications.