Head and Neck Cancer

• EMA approval · 2026-01-28
  EMA Authorised: Erbitux (cetuximab) — Merck Europe B.V.

  EMA authorised Erbitux (cetuximab) for head and neck cancer and colorectal cancer under Merck Europe B.V.

• FDA approval · 2025-11-12
  FDA Tentative Approval: FLUOROURACIL — Supplemental Application (Gland Pharma Limited)

  FDA Tentative Approval for Fluorouracil from Gland Pharma Limited under an ANDA, indicating a pathway to U.S. market subject to regulatory t…

• EMA approval · 2025-08-04
  EMA Authorised: Docetaxel Kabi (docetaxel) — Fresenius Kabi Deutschland GmbH

  The EMA authorised Docetaxel Kabi (docetaxel) from Fresenius Kabi Deutschland GmbH for multiple cancer indications, including head and neck …

• FDA approval · 2025-05-13
  FDA Approved: DOCETAXEL — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approves a generic docetaxel product under an original ANDA for Meitheal Pharmaceuticals Inc.

• EMA approval · 2025-02-13
  EMA Authorised: Docetaxel Accord (docetaxel) — Accord Healthcare S.L.U.

  The EMA authorised Docetaxel Accord (docetaxel) from Accord Healthcare for multiple cancer indications, including head and neck cancer, non-…

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• EMA approval · 2024-07-31
  EMA Authorised: Taxotere (docetaxel) — Sanofi Winthrop Industrie

  The EMA authorised Taxotere (docetaxel) for multiple cancer indications including head and neck cancer, non-small cell lung cancer, gastric …

• FDA approval · 2023-09-15
  FDA Approved: DOCETAXEL — Supplemental Application (Gland Pharma Limited)

  FDA approved a supplemental application for docetaxel from Gland Pharma Limited under an ANDA for the generic product.

• FDA approval · 2022-10-18
  FDA Approved: FLUOROURACIL — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved a supplemental application for fluorouracil submitted by Taro Pharmaceuticals U.S.A., Inc., approving changes to the product’s …

• FDA approval · 2022-09-14
  FDA Approved: FLUOROURACIL — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for fluorouracil submitted by BluePoint Laboratories, indicating approval of an ANDA supplement. Thi…

• FDA approval · 2021-01-14
  FDA Approved: DOCETAXEL — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Hikma Pharmaceuticals USA Inc.'s original application for generic docetaxel. Docetaxel is a chemotherapy agent used to treat mu…

• FDA approval · 2020-09-10
  FDA Approved: DOCETAXEL — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for a generic docetaxel product (docetaxel anhydrous) from Mylan Institutional LLC.

• FDA approval · 2019-09-05
  FDA Approved: DOCETAXEL — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for docetaxel (docetaxel anhydrous) by Mylan Institutional LLC under ANDA 210072.

• FDA approval · 2019-04-01
  FDA Approved: DOCETAXEL — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for Docetaxel from Dr. Reddy's Laboratories Inc., authorizing the generic product under the approved…

• FDA approval · 2019-03-13
  FDA Approved: DOCETAXEL ANHYDROUS — Supplemental Application (Meitheal Pharmaceuticals Inc)

  The FDA approved a supplemental application from Meitheal Pharmaceuticals to market docetaxel anhydrous as a generic chemotherapy drug.

• FDA approval · 2018-07-02
  FDA Approved: DOCETAXEL — Original Application (Mylan Institutional LLC)

  FDA approved an original application for a generic docetaxel product (docetaxel anhydrous) from Mylan Institutional LLC. The generic is an i…

• FDA approval · 2018-04-30
  FDA Approved: DOCETAXEL — Original Application (Mylan Institutional LLC)

  The FDA approved Mylan Institutional LLC's original application for a generic docetaxel anhydrous product (ANDA208859).

• FDA approval · 2017-05-25
  FDA Approved: ETHYOL — Supplemental Application (Legacy Pharma USA Inc.)

  FDA approved a supplemental application for Ethyol (amifostine) submitted by Legacy Pharma USA Inc.

• FDA approval · 2017-03-17
  FDA Approved: CISPLATIN — Original Application (Sagent Pharmaceuticals)

  FDA approved Sagent Pharmaceuticals' original application for cisplatin, a generic injectable chemotherapy agent (ANDA approval).

• FDA approval · 2017-01-19
  FDA Approved: CISPLATIN — Supplemental Application (WG Critical Care, LLC)

  The FDA approved a supplemental application for cisplatin submitted by WG Critical Care, LLC.

• FDA approval · 2017-01-06
  FDA Approved: FLUOROURACIL — Supplemental Application (Fresenius Kabi USA, LLC)

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

• FDA approval · 2016-12-27
  FDA Approved: FLUOROURACIL — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for Fluorouracil (5-fluorouracil) from Eugia US LLC.

• FDA approval · 2016-12-14
  FDA Approved: FLUOROURACIL — Supplemental Application (Eugia US LLC)

  The FDA has approved a supplemental application for Fluorouracil from Eugia US LLC, formalizing an update to the product under the ANDA path…

• FDA approval · 2016-02-17
  FDA Approved: FLUOROURACIL — Original Application (Sagent Pharmaceuticals)

  FDA approves an Original Application for Fluorouracil from Sagent Pharmaceuticals, establishing a generic injectable form of the chemotherap…

• FDA approval · 2015-08-18
  FDA Approved: FLUOROURACIL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for fluorouracil submitted by Mylan Pharmaceuticals, resulting in an updated regulatory status for t…

• FDA approval · 2014-11-05
  FDA Approved: DOCETAXEL — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approves the original (ANDA) application for docetaxel generic produced by Dr. Reddy's Laboratories.