Central Precocious Puberty

• 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 · 2025-11-14
  FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for LUPRON DEPOT-PED (leuprolide acetate) from AbbVie to support an expanded pediatric indication fo…

• 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: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Lupron Depot-PED (leuprolide acetate) from AbbVie, updating its labeling under a supplemental ap…

• 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.

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• FDA approval · 2025-09-23
  FDA Approved: SUPPRELIN LA — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for SUPPRELIN LA (histrelin acetate) from Endo USA, Inc., signaling an updated/expanded use or label…

• 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…

• 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 · 2025-05-22
  FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Lupron Depot-Ped (leuprolide acetate) from AbbVie Inc. The approval updates the product's la…

• 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: FENSOLVI — Supplemental Application (TOLMAR Inc.)

  FDA approved a supplemental application for FENSOLVI (leuprolide acetate) filed by Tolmar Inc. This action updates the product labeling.

• 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 · 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 · 2023-12-04
  FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2023-04-14
  FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for LUPRON DEPOT-PED (leuprolide acetate) filed by AbbVie to expand its pediatric indication.

• 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 · 2022-11-25
  FDA Approved: FENSOLVI — Supplemental Application (TOLMAR Inc.)

  FDA approved Tolmar Inc.'s supplemental application for FENSOLVI (leuprolide acetate). This action updates the original approval via a suppl…

• 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 · 2022-04-22
  FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for LUPRON DEPOT-PED (Leuprolide acetate) from AbbVie Inc., supporting its pediatric use. This r…

• FDA approval · 2022-04-22
  FDA Approved: FENSOLVI — Supplemental Application (TOLMAR Inc.)

  FDA approved a supplemental application for FENSOLVI (leuprolide acetate) from Tolmar Inc., expanding its labeling.

• FDA approval · 2022-04-22
  FDA Approved: SUPPRELIN LA — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for SUPPRELIN LA (histrelin acetate) from Endo USA, Inc. The action concerns the drug’s labeling/ind…

• FDA approval · 2021-11-12
  FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for LUPRON DEPOT-PED (leuprolide acetate) by AbbVie, updating its labeling for pediatric use.