Esophageal Cancer

• EMA approval · 2026-03-03
  EMA Authorised: Vyloy (zolbetuximab) — Astellas Pharma Europe B.V.

  EMA authorised Vyloy (zolbetuximab) for gastric and esophageal cancers; the medicine has orphan designation and is developed by Astellas Pha…

• FDA approval · 2023-06-16
  FDA Approved: CARBOPLATIN — Supplemental Application (Apotex Corp.)

  FDA approved Apotex Corp.'s supplemental application for generic carboplatin. This action permits Apotex to market a generic carboplatin for…

• 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 · 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.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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 · 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.

• 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 · 2012-03-15
  FDA Approved: CISPLATIN — Supplemental Application (Teva Parenteral Medicines, Inc.)

  FDA approved a supplemental application for cisplatin from Teva Parenteral Medicines, Inc., marking an approved change to the drug's regulat…

• 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 · 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 · 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.