Head and Neck Cancer

• FDA approval · 2014-10-14
  FDA Approved: KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) — Supplemental Application (Cardinal Health 414, LLC)

  The FDA approved a supplemental application to authorize Cardinal Health 414, LLC to prepare the Lymphoseek radiopharmaceutical kit (technet…

• FDA approval · 2014-07-10
  FDA Approved: DOCETAXEL — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira, Inc.'s supplemental application for Docetaxel.

• FDA approval · 2014-06-13
  FDA Approved: KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) — Supplemental Application (Cardinal Health 414, LLC)

  FDA approved a supplemental application for a kit used to prepare Lymphoseek (tilmanocept) with technetium-99m, submitted by Cardinal Health…

• FDA approval · 2012-11-13
  FDA Approved: CISPLATIN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for cisplatin filed by Fresenius Kabi USA, LLC. This action confirms the continued approval of cispl…

• FDA approval · 2012-07-17
  FDA Approved: FLUOROURACIL — Original Application (Eugia US LLC)

  FDA-approved the original ANDA for fluorouracil from Eugia US LLC, granting a generic version of fluorouracil for cancer chemotherapy.

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• FDA approval · 2012-07-17
  FDA Approved: FLUOROURACIL — Original Application (Eugia US LLC)

  FDA approved the original ANDA for Fluorouracil by Eugia US LLC, enabling the marketing of a generic fluorouracil chemotherapy product.

• FDA approval · 2011-08-26
  FDA Approved: CISPLATIN — Supplemental Application (WG Critical Care, LLC)

  FDA approved a supplemental application for cisplatin submitted by WG Critical Care, LLC, resulting in an updated regulatory status for the …

• FDA approval · 2011-06-29
  FDA Approved: DOCETAXEL — Original Application (Baxter Healthcare Corporation)

  FDA approved the original application for docetaxel by Baxter Healthcare Corporation, marking its initial U.S. approval as a cancer therapy.…

• FDA approval · 2010-03-05
  FDA Approved: FLUOROURACIL — Original Application (Taro Pharmaceuticals U.S.A., Inc.)

  The FDA approved the original application for a generic fluorouracil product manufactured by Taro Pharmaceuticals U.S.A., Inc.

• FDA approval · 2008-11-07
  FDA Approved: ETHYOL — Supplemental Application (Legacy Pharma USA Inc.)

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

• FDA approval · 2007-04-26
  FDA Approved: FLUOROURACIL — Original Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare’s original application for Fluorouracil as a generic injectable chemotherapy agent for multiple cancers.