Breast Cancer

• FDA label_change · 2025-09-23
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for Leuprolide acetate filed by NorthStar RxLLC, indicating an update to the product labeling.

• FDA label_change · 2025-09-23
  FDA Approved: ZOLADEX — Supplemental Application (TerSera Therapeutics LLC)

  FDA approved a supplemental application for ZOLADEX (goserelin) submitted by TerSera Therapeutics LLC. The approval updates the label to ref…

• FDA label_change · 2025-06-27
  FDA Approved: PERJETA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for PERJETA (pertuzumab) from Genentech, Inc., resulting in updated labeling under the existing appr…

• FDA label_change · 2025-01-15
  FDA Approved: MARGENZA — Supplemental Application (TerSera Therapeutics LLC)

  FDA approved a supplemental application for Margenza (margetuximab-cmkb) submitted by TerSera Therapeutics LLC, resulting in changes to the …

• FDA label_change · 2025-01-03
  FDA Approved: DOXORUBICIN HYDROCHLORIDE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for doxorubicin hydrochloride from Zydus Lifesciences Limited, updating the labeling for the product…

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• FDA label_change · 2024-05-17
  FDA Approved: ANASTROZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for Anastrozole (generic), resulting in updated labeling for this product.

• FDA label_change · 2023-10-23
  FDA Approved: FULVESTRANT — Supplemental Application (Accord Healthcare Inc.)

  The FDA approved a supplemental application for Fulvestrant from Accord Healthcare Inc., updating the labeling for this generic product.

• FDA label_change · 2022-12-05
  FDA Approved: TRODELVY — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for TRODELVY (sacituzumab govitecan) filed by Gilead Sciences, resulting in labeling changes for…

• FDA label_change · 2022-10-27
  FDA Approved: EXEMESTANE — Supplemental Application (Upsher-Smith Laboratories, Inc.)

  FDA has approved a supplemental application for Exemestane by Upsher-Smith Laboratories, resulting in labeling changes for the product.

• FDA label_change · 2021-06-17
  FDA Approved: ZOLADEX — Supplemental Application (TerSera Therapeutics LLC)

  FDA supplemental application for ZOLADEX (goserelin) submitted by TerSera Therapeutics LLC, likely related to labeling changes for the produ…

• FDA label_change · 2021-05-12
  FDA Approved: FULVESTRANT — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Fulvestrant from Fresenius Kabi USA, LLC. The submission appears to concern a labeling-related u…

• FDA label_change · 2020-07-28
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental labeling application for FASLODEX (fulvestrant) from AstraZeneca Pharmaceuticals LP. The update relates to label…

• EMA label_change · 2020-03-27
  No change to product information for breast cancer medicine Tyverb following re-assessment of data

  European Medicines Agency states there is no change to the product information for the breast cancer medicine Tyverb after a re-assessment o…

• FDA label_change · 2020-03-19
  FDA Approved: ONTRUZANT — Supplemental Application (Organon LLC)

  FDA approves a supplemental application for ONTRUZANT (trastuzumab) filed by Organon LLC, resulting in changes to the product labeling.

• FDA label_change · 2018-07-05
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for FASLODEX (fulvestrant) submitted by AstraZeneca Pharmaceuticals LP. The decision involves change…

• FDA label_change · 2017-05-12
  FDA Approved: FARESTON — Supplemental Application (Kyowa Kirin, Inc.)

  FDA supplemental approval for Fareston (toremifene citrate) to update the labeling for this breast cancer therapy.

• FDA label_change · 2017-01-24
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for FASLODEX (fulvestrant) filed by AstraZeneca, resulting in labeling updates for the drug.

• FDA label_change · 2014-07-28
  FDA Approved: EXEMESTANE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Exemestane filed by Mylan Pharmaceuticals Inc., updating labeling for the aromatase inhibito…

• FDA label_change · 2014-05-30
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) from URONOVA Pharmaceuticals. This notice relates to regulatory ac…

• FDA label_change · 2013-06-26
  FDA Approved: DOCETAXEL — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for docetaxel, resulting in changes to the product labeling. The changes may include updates to indi…

• FDA label_change · 2013-04-08
  FDA Approved: ANASTROZOLE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved the supplemental application for Accord Healthcare's generic anastrozole, updating the labeling for this product.

• FDA label_change · 2013-01-25
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) from Uronova Pharmaceuticals, resulting in labeling changes for th…

• FDA label_change · 2012-07-13
  FDA Approved: FASLODEX — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for FASLODEX (fulvestrant) from AstraZeneca Pharmaceuticals LP to update the drug's labeling.

• FDA label_change · 2011-04-08
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  The FDA approved a supplemental application for VABRINTY (leuprolide acetate) from URONOVA PHARMACEUTICALS, INC.

• FDA label_change · 2011-03-21
  FDA Approved: FARESTON — Supplemental Application (Kyowa Kirin, Inc.)

  FDA approved a supplemental application for Fareston (toremifene citrate) submitted by Kyowa Kirin, Inc., resulting in a labeling update for…