Uterine Fibroids

• 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 · 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.

• FDA label_change · 2022-08-05
  FDA Approved: MYFEMBREE — Supplemental Application (Sumitomo Pharma America, Inc)

  FDA approved a supplemental application for MYFEMBREE (relugolix, estradiol hemihydrate, and norethindrone acetate) from Sumitomo Pharma Ame…

• FDA label_change · 2021-08-02
  FDA Approved: ORIAHNN — Supplemental Application (AbbVie Inc.)

  FDA supplemental application for ORIAHNN (elagolix with estradiol and norethindrone) from AbbVie Inc. seeks a label update. The target condi…

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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 · 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 · 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 · 2013-01-25
  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 · 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.