Differentiated Thyroid Carcinoma

• FDA approval · 2024-11-26
  FDA Approved: SORAFENIB — Supplemental Application (Dr.Reddys Laboratories Inc)

  FDA approved a supplemental application for sorafenib submitted by Dr. Reddy's Laboratories Inc. This action provides supplemental approval …

• FDA approval · 2024-06-12
  FDA Approved: RETEVMO — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for RETEVMO (selpercatinib) from Eli Lilly and Company.

• FDA approval · 2024-03-05
  FDA Approved: SORAFENIB TOSYLATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA granted a supplemental approval for sorafenib tosylate (generic sorafenib) by Mylan Pharmaceuticals Inc., allowing the generic product t…

• FDA approval · 2023-09-12
  FDA Approved: SORAFENIB — Supplemental Application (Yabao Pharmaceutical Co., Ltd. Beijing)

  FDA approved a supplemental application for Sorafenib by Yabao Pharmaceutical Co., Ltd. Beijing under an ANDA.

• FDA approval · 2023-09-12
  FDA Approved: SORAFENIB — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Sorafenib from Teva Pharmaceuticals, indicating regulatory action for the generic product. Soraf…

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• FDA approval · 2023-04-12
  FDA Approved: SORAFENIB — Original Application (Torrent Pharmaceuticals Limited)

  The FDA approved Torrent Pharmaceuticals' original ANDA for sorafenib, a generic version of Nexavar, expanding access to the cancer therapy.

• FDA approval · 2022-11-09
  FDA Approved: SORAFENIB — Original Application (Yabao Pharmaceutical Co., Ltd. Beijing)

  FDA approved a generic sorafenib product from Yabao Pharmaceutical Co., Ltd. Beijing (ANDA 209050). The approval covers the same indications…

• FDA approval · 2022-06-07
  FDA Approved: SORAFENIB — Original Application (Dr.Reddys Laboratories Inc)

  FDA approves the original application for a generic sorafenib product from Dr. Reddy's Laboratories Inc, expanding access to the cancer drug…

• FDA approval · 2021-06-11
  FDA Approved: HICON — Supplemental Application (Jubilant DraxImage Inc., dba Jubilant Radiopharma)

  FDA approved a supplemental application for HICON (Sodium I-131) from Jubilant DraxImage Inc., dba Jubilant Radiopharma.

• FDA approval · 2020-11-12
  FDA Approved: SORAFENIB — Original Application (Teva Pharmaceuticals, Inc.)

  The FDA approved Teva's original application for a generic sorafenib product, enabling a generic version of the cancer drug Sorafenib to be …

• FDA approval · 2020-09-10
  FDA Approved: SORAFENIB TOSYLATE — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a generic sorafenib tosylate product from Mylan under an original application. Sorafenib is indicated for hepatocellular ca…

• FDA approval · 2020-05-08
  FDA Approved: RETEVMO — Original Application (Eli Lilly and Company)

  FDA approved Retevmo (selpercatinib) from Eli Lilly in its original NDA. The approval covers RET fusion-positive non-small cell lung cancer …

• FDA approval · 2020-03-12
  FDA Approved: THYROGEN — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for THYROGEN (thyrotropin alfa) from Genzyme Corporation, updating the labeling to support its use i…

• FDA approval · 2018-06-06
  FDA Approved: LENVIMA — Supplemental Application (Eisai Inc.)

  FDA approved a supplemental application for LENVIMA (lenvatinib) submitted by Eisai Inc.

• FDA approval · 2017-12-22
  FDA Approved: NEXAVAR — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Nexavar (sorafenib) submitted by Bayer HealthCare Pharmaceuticals Inc.

• FDA approval · 2017-04-24
  FDA Approved: THYROGEN — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for THYROGEN (thyrotropin alfa) submitted by Genzyme Corporation. The action updates the labeling to…

• FDA approval · 2017-02-24
  FDA Approved: TIROSINT SOL — Supplemental Application (IBSA Pharma Inc.)

  The FDA approved a supplemental application for TIROSINT SOL (levothyroxine sodium) from IBSA Pharma Inc., a thyroid hormone replacement the…

• FDA approval · 2015-02-13
  FDA Approved: LENVIMA — Original Application (Eisai Inc.)

  FDA approves LENVIMA (lenvatinib) in its original application for the treatment of differentiated thyroid carcinoma.

• FDA approval · 2015-02-03
  FDA Approved: HICON — Supplemental Application (Jubilant DraxImage Inc., dba Jubilant Radiopharma)

  FDA approved a supplemental application for HICON (Sodium iodide I-131) from Jubilant DraxImage Inc., dba Jubilant Radiopharma.

• FDA approval · 2014-03-21
  FDA Approved: THYROGEN — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for THYROGEN (thyrotropin alfa) submitted by Genzyme Corporation.

• FDA approval · 2013-05-07
  FDA Approved: THYROGEN — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for THYROGEN (thyrotropin alfa) from Genzyme Corporation.

• FDA approval · 2012-08-24
  FDA Approved: NEXAVAR — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for Nexavar (sorafenib) submitted by Bayer HealthCare Pharmaceuticals Inc.

• FDA approval · 2012-07-27
  FDA Approved: THYROGEN — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for THYROGEN (thyrotropin alfa) from Genzyme Corporation.

• FDA approval · 2007-12-14
  FDA Approved: THYROGEN — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for THYROGEN (thyrotropin alfa) from Genzyme Corporation.

• FDA approval · 2007-04-18
  FDA Approved: HICON — Supplemental Application (Jubilant DraxImage Inc., dba Jubilant Radiopharma)

  The FDA approved a supplemental application for HICON (sodium iodide I-131) submitted by Jubilant DraxImage Inc., dba Jubilant Radiopharma.