Prostate 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: LEUPROLIDE ACETATE — Supplemental Application (Meitheal Pharmaceuticals Inc)

  FDA approved a supplemental application for Leuprolide acetate submitted by Meitheal Pharmaceuticals Inc.

• 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 · 2025-03-11
  FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)

  FDA supplemental application for TRELSTAR (triptorelin pamoate) submitted by Verity Pharmaceuticals Inc. to update labeling, potentially exp…

• FDA label_change · 2024-01-23
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) from Uronova Pharmaceuticals to modify the drug's labeling.

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• 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 · 2020-03-20
  FDA Approved: BICALUTAMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Bicalutamide from Sun Pharmaceutical Industries, indicating a label update or related change…

• FDA label_change · 2018-12-30
  FDA Approved: BICALUTAMIDE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for bicalutamide by Accord Healthcare, resulting in changes to the product labeling.

• FDA label_change · 2017-05-19
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Leuprolide acetate from Sun Pharmaceutical Industries, updating the labeling for this generi…

• FDA label_change · 2016-02-29
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) from URONOVA Pharmaceuticals. The supplemental action updates the …

• FDA label_change · 2015-12-10
  FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)

  The FDA granted a supplemental application for ZYTIGA (abiraterone acetate) to update its labeling, expanding or modifying its approved indi…

• 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 · 2013-01-25
  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 · 2012-07-19
  FDA Approved: BICALUTAMIDE — Supplemental Application (Viona Pharmaceuticals Inc.)

  The FDA granted a supplemental approval for bicalutamide from Viona Pharmaceuticals, indicating an update to the approved product (labeling/…

• FDA label_change · 2012-07-03
  FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for ZYTIGA (abiraterone acetate) submitted by Janssen Biotech, Inc.

• 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 · 2011-01-14
  FDA Approved: ZOLADEX — Supplemental Application (TerSera Therapeutics LLC)

  FDA approved a supplemental application for ZOLADEX (goserelin) from TerSera Therapeutics LLC. The approval includes changes to the product …

• FDA label_change · 2008-05-07
  FDA Approved: ZOLADEX — Supplemental Application (TerSera Therapeutics LLC)

  FDA approved a supplemental application for ZOLADEX (goserelin) submitted by TerSera Therapeutics LLC.