Vasomotor Symptoms Due to Menopause

• FDA approval · 2024-12-16
  FDA Approved: VEOZAH — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for VEOZAH (fezolinetant) submitted by Astellas Pharma US, Inc.

• FDA approval · 2024-08-31
  FDA Approved: VEOZAH — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for VEOZAH (fezolinetant) submitted by Astellas Pharma US, Inc. The action updates the product label…

• FDA approval · 2024-03-04
  FDA Approved: DUAVEE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for Duavee (conjugated estrogens/bazedoxifene) submitted by Wyeth Pharmaceuticals LLC (a subsidiary …

• FDA approval · 2024-02-15
  FDA Approved: EVAMIST — Supplemental Application (Padagis US LLC)

  The FDA approved a supplemental application for Evamist (estradiol) submitted by Padagis US LLC, as part of an additional regulatory action.

• FDA approval · 2024-02-15
  FDA Approved: COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) — Supplemental Application (Noven Therapeutics, LLC)

  The FDA approved a supplemental application for COMBIPATCH (estradiol/norethindrone acetate transdermal system) filed by Noven Therapeutics,…

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• FDA approval · 2021-11-15
  FDA Approved: CLIMARA PRO — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for CLIMARA PRO, the estradiol/levonorgestrel transdermal patch from Bayer HealthCare Pharmaceutical…

• FDA approval · 2017-11-01
  FDA Approved: VIVELLE-DOT — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Vivelle-Dot (estradiol) submitted by Sandoz Inc, updating the product’s labeling via a supplemen…

• FDA approval · 2017-11-01
  FDA Approved: DUAVEE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application for Duavee (conjugated estrogens/bazedoxifene) from Wyeth/Pfizer to update the product labeling …

• FDA approval · 2014-03-11
  FDA Approved: EVAMIST — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for EVAMIST (estradiol) by Padagis US LLC.