Menopause
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-08-21EMA Authorised: Veoza (fezolinetant) — Astellas Pharma Europe B.V.
Authorised European marketing approval for Veoza (fezolinetant) by Astellas Pharma Europe B.V. for menopause-related hot flashes.
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EMA approval · 2026-04-21EMA Authorised: Veoza (fezolinetant) — Astellas Pharma Europe B.V.
The European Medicines Agency authorised Veoza (fezolinetant) from Astellas Pharma Europe B.V. for the treatment of menopausal vasomotor sym…
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EMA approval · 2026-04-09EMA Authorised: Fylrevy (estetrol monohydrate) — Gedeon Richter Plc.
EMA authorised Fylrevy (estetrol monohydrate) for menopausal hormone therapy. Gedeon Richter Plc. is the marketing authorisation holder.
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FDA approval · 2026-02-12FDA Approved: BIJUVA — Supplemental Application (Mayne Pharma)
The FDA approved a supplemental application for BIJUVA (estradiol and progesterone) submitted by Mayne Pharma.
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EMA approval · 2025-11-27EMA Authorised: Lynkuet (elinzanetant) — Bayer AG
The European Medicines Agency authorised Lynkuet (elinzanetant) from Bayer AG for menopausal symptoms including hot flashes and indications …
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FDA approval · 2025-10-24FDA Approved: LYNKUET — Original Application (Bayer HealthCare Pharmaceuticals Inc.)
FDA approved Lynkuet (elinzanetant) from Bayer HealthCare Pharmaceuticals Inc. under an original NDA.
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FDA approval · 2025-10-15FDA Approved: ESTROGENS, CONJUGATED — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approved the original application for a generic conjugated estrogens product from Ingenus Pharmaceuticals, LLC, marking entry of this ge…
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FDA approval · 2025-04-29FDA Approved: DIVIGEL — Supplemental Application (Vertical Pharmaceuticals, LLC)
The FDA approved a supplemental application for Divigel (estradiol) from Vertical Pharmaceuticals, LLC. The approval updates the product lab…
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FDA approval · 2024-10-23FDA Approved: ESTRADIOL — Original Application (ANI Pharmaceuticals, Inc.)
The FDA approved ANI Pharmaceuticals' generic estradiol product under an original application.
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FDA approval · 2024-08-02FDA Approved: LYLLANA — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for LYLLANA (estradiol) submitted by Amneal Pharmaceuticals LLC.
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FDA approval · 2024-06-13FDA Approved: ESTRADIOL — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for Estradiol (ESTRADIOL) from NorthStar Rx LLC under the ANDA program.
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FDA approval · 2024-02-15FDA Approved: ESTROGEL — Supplemental Application (ASCEND Therapeutics US, LLC)
The FDA approved a supplemental application for ESTROGEL (estradiol) from ASCEND Therapeutics US, LLC.
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FDA approval · 2024-02-15FDA Approved: ELESTRIN — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for ELESTRIN (estradiol) from Viatris Specialty LLC. The approval updates the labeling to incorporat…
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FDA approval · 2024-02-15FDA Approved: CLIMARA PRO — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
FDA approved a supplemental application for Climara Pro, a transdermal patch combining estradiol and levonorgestrel, from Bayer HealthCare P…
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FDA approval · 2024-02-15FDA Approved: BIJUVA — Supplemental Application (Mayne Pharma)
The FDA approved a supplemental application for BIJUVA, a combination of estradiol and progesterone, submitted by Mayne Pharma. The approval…
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FDA approval · 2023-11-20FDA Approved: LYLLANA — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for LYLLANA (estradiol) from Amneal Pharmaceuticals LLC (ANDA 211396).
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FDA approval · 2023-11-14FDA Approved: ESTRADIOL — Original Application (Padagis Israel Pharmaceuticals Ltd)
FDA approved an Estradiol generic product from Padagis Israel Pharmaceuticals Ltd under an Original Application, enabling its use for estrog…
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FDA approval · 2023-10-02FDA Approved: ANGELIQ — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
FDA approved a supplemental application for Angeliq (drospi renone and estradiol) from Bayer, updating labeling for postmenopausal indicatio…
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FDA approval · 2023-09-06FDA Approved: ESTRADIOL — Original Application (ANI Pharmaceuticals, Inc.)
The FDA approved ANI Pharmaceuticals' original application for a generic Estradiol product.
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FDA approval · 2023-08-24FDA Approved: ESTRADIOL — Original Application (NorthStar Rx LLC)
FDA approved NorthStar Rx LLC's Estradiol as an original-application generic product (ANDA217610).
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FDA approval · 2023-04-28FDA Approved: ESTRADIOL VALERATE — Original Application (Xiromed, LLC)
The FDA approved Xiromed, LLC's Estradiol Valerate as an original-application generic (ANDA 216656), authorizing its marketing for approved …
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FDA approval · 2022-08-10FDA Approved: ESTRADIOL — Original Application (Xiromed, LLC)
FDA approved Xiromed, LLC's Estradiol Gel 0.1% as an original application (ANDA) for generic estradiol gel.
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FDA approval · 2021-11-30FDA Approved: ESTROGEL — Supplemental Application (ASCEND Therapeutics US, LLC)
FDA approved a supplemental application for ESTROGEL (estradiol) from ASCEND Therapeutics US, LLC, expanding the product's labeling for meno…
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FDA approval · 2021-06-22FDA Approved: BIJUVA — Supplemental Application (Mayne Pharma)
The FDA approved a supplemental application for BIJUVA (estradiol and progesterone) submitted by Mayne Pharma.
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FDA approval · 2019-05-03FDA Approved: DEPO-ESTRADIOL — Supplemental Application (Pharmacia & Upjohn Company LLC)
FDA approved a supplemental application for Depo-Estradiol (estradiol cypionate) by Pharmacia & Upjohn Company LLC under ANDA085470.