Uterine Fibroids
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-12-17FDA Approved: ORIAHNN — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for ORIAHNN, a fixed-dose combination of elagolix, estradiol, and norethindrone by AbbVie. The appro…
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EMA approval · 2025-11-21EMA Authorised: Yselty (linzagolix choline) — Theramex Ireland Limited
EMA authorised Yselty (linzagolix choline) for uterine fibroids (leiomyoma); Theramex Ireland Limited is the marketing authorisation holder.
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FDA approval · 2025-09-23FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)
FDA approved a supplemental application for TRELSTAR (triptorelin pamoate) from Verity Pharmaceuticals Inc., authorizing an updated indicati…
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FDA approval · 2025-09-23FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Eugia US LLC)
FDA approved a supplemental application for leuprolide acetate (generic) submitted by Eugia US LLC under an ANDA.
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FDA approval · 2025-09-23FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Leuprolide acetate from Amneal Pharmaceuticals LLC, granting approval for a generic version of t…
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FDA approval · 2025-09-19FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Meitheal Pharmaceuticals Inc)
FDA approved a supplemental application for Leuprolide acetate from Meitheal Pharmaceuticals Inc.
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FDA approval · 2025-02-11FDA Approved: CAMCEVI — Supplemental Application (Accord BioPharma, Inc.)
FDA approved a supplemental application for CAMCEVI (leuprolide) from Accord BioPharma, Inc., expanding regulatory approval for this long-ac…
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FDA approval · 2024-11-14FDA Approved: LUTRATE DEPOT — Supplemental Application (Avyxa Pharma, LLC)
FDA approved a supplemental application for LUTRATE DEPOT (leuprolide acetate) from Avyxa Pharma, LLC. This action updates the product’s lab…
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FDA approval · 2024-10-17FDA Approved: LEUPROLIDE ACETATE — Original Application (UBI Pharma Inc.)
FDA approves Leuprolide acetate under an Original Application, establishing a generic version by UBI Pharma Inc. for the listed indications.
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FDA approval · 2024-04-30FDA Approved: MYFEMBREE — Supplemental Application (Sumitomo Pharma America, Inc)
FDA approved a supplemental application for MYFEMBREE, a relugolix/estradiol hemihydrate/norethindrone acetate combination, expanding its la…
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FDA approval · 2023-12-04FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) from AbbVie, updating the product's label under a supplemental…
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FDA approval · 2023-06-05FDA Approved: ORIAHNN — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for Oriahnn (elagolix, estradiol, and norethisterone) from AbbVie. This action confirms the regulato…
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FDA approval · 2023-02-28FDA Approved: LUTRATE DEPOT — Supplemental Application (Avyxa Pharma, LLC)
The FDA approved a supplemental application for LUTRATE DEPOT (leuprolide acetate) submitted by Avyxa Pharma, LLC.
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FDA approval · 2022-06-06FDA Approved: LEUPROLIDE ACETATE — Original Application (Eugia US LLC)
The FDA approved Eugia US LLC's generic Leuprolide Acetate under an Original Application (ANDA 212963), making a generic version of this med…
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FDA approval · 2021-08-13FDA Approved: LEUPROLIDE ACETATE — Original Application (NorthStar RxLLC)
FDA approved the Leuprolide acetate original application (ANDA213829) for a generic version, issued to NorthStar RxLLC.
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FDA approval · 2021-05-26FDA Approved: MYFEMBREE — Original Application (Sumitomo Pharma America, Inc)
FDA approved MYFEMBREE, a fixed-dose combination of relugolix, estradiol hemihydrate, and norethindrone acetate, for the treatment of heavy …
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FDA approval · 2021-02-01FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for Leuprolide acetate submitted by Sandoz Inc. This action approves changes under the generic d…
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FDA approval · 2020-05-29FDA Approved: ORIAHNN — Original Application (AbbVie Inc.)
FDA approved ORIAHNN, a fixed-dose combination of elagolix, estradiol, and norethindrone, from AbbVie in an Original Application, for the tr…
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FDA approval · 2019-08-28FDA Approved: ORILISSA — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for ORILISSA (elagolix) submitted by AbbVie, likely updating labeling and/or indications based o…
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FDA approval · 2019-03-04FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) from AbbVie Inc.
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FDA approval · 2019-02-15FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)
FDA approved a supplemental application for VABRINTY (leuprolide acetate) from URONOVA Pharmaceuticals, resulting in changes to the labeling…
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FDA approval · 2018-12-10FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) submitted by AbbVie, resulting in a labeling update via a supp…
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FDA approval · 2017-05-19FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for leuprolide acetate from Sandoz Inc, authorizing an update related to this product.
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FDA approval · 2017-05-19FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Meitheal Pharmaceuticals Inc)
FDA approved a supplemental application for leuprolide acetate from Meitheal Pharmaceuticals Inc, related to the existing approval for this …
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FDA approval · 2017-01-13FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)
The FDA approved a supplemental application for VABRINTY (leuprolide acetate) submitted by URONOVA PHARMACEUTICALS, INC., resulting in label…