Endometriosis

• FDA approval · 2025-11-24
  FDA Approved: SYNAREL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Synarel (nafarelin acetate) submitted by Pfizer Laboratories Div Pfizer Inc. The approval update…

• FDA approval · 2025-09-23
  FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)

  FDA approved a supplemental application for TRELSTAR (triptorelin pamoate) from Verity Pharmaceuticals Inc., authorizing an updated indicati…

• FDA approval · 2025-09-23
  FDA 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.

• FDA approval · 2025-09-23
  FDA Approved: TRIPTODUR — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for TRIPTODUR (triptorelin) from Azurity Pharmaceuticals, Inc.

• FDA approval · 2025-09-23
  FDA 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 · 2025-09-19
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Meitheal Pharmaceuticals Inc)

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

• FDA approval · 2025-02-11
  FDA 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…

• FDA approval · 2024-11-14
  FDA 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…

• FDA approval · 2024-10-17
  FDA 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.

• FDA approval · 2024-07-17
  FDA Approved: MYFEMBREE — Supplemental Application (Sumitomo Pharma America, Inc)

  FDA approved a supplemental application for MYFEMBREE, a fixed-dose combination of relugolix with estradiol hemihydrate and norethindrone ac…

• FDA approval · 2024-04-30
  FDA 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…

• FDA approval · 2023-12-04
  FDA 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…

• FDA approval · 2023-02-28
  FDA Approved: LUTRATE DEPOT — Supplemental Application (Avyxa Pharma, LLC)

  The FDA approved a supplemental application for LUTRATE DEPOT (leuprolide acetate) submitted by Avyxa Pharma, LLC.

• FDA approval · 2023-01-27
  FDA Approved: MYFEMBREE — Supplemental Application (Sumitomo Pharma America, Inc)

  FDA approved a supplemental application for MYFEMBREE (relugolix, estradiol hemihydrate, and norethindrone acetate) submitted by Sumitomo Ph…

• FDA approval · 2022-10-28
  FDA Approved: LEUPROLIDE ACETATE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' original ANDA for Leuprolide acetate, a generic version of Lupron.

• FDA approval · 2022-06-06
  FDA 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…

• FDA approval · 2021-08-13
  FDA Approved: LEUPROLIDE ACETATE — Original Application (NorthStar RxLLC)

  FDA approved the Leuprolide acetate original application (ANDA213829) for a generic version, issued to NorthStar RxLLC.

• FDA approval · 2021-02-01
  FDA 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…

• FDA approval · 2020-03-18
  FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) submitted by AbbVie Inc.

• FDA approval · 2019-08-28
  FDA 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…

• FDA approval · 2019-03-04
  FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) from AbbVie Inc.

• FDA approval · 2019-02-15
  FDA 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…

• FDA approval · 2018-12-10
  FDA 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…

• FDA approval · 2018-07-23
  FDA Approved: ORILISSA — Original Application (AbbVie Inc.)

  FDA approved Orilissa (elagolix) from AbbVie under NDA210450, marking the original approval of the therapy. It is indicated for the manageme…

• FDA approval · 2017-05-19
  FDA 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.