Genitourinary Syndrome of Menopause

• FDA label_change · 2025-04-22
  FDA Approved: PREMARIN VAGINAL — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for Premarin Vaginal (conjugated estrogens) to update the product's labeling under Wyeth Pharmaceuti…

• FDA label_change · 2024-08-30
  FDA Approved: ESTRADIOL VAGINAL INSERTS — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental labeling application for Estradiol vaginal inserts by Glenmark Pharmaceuticals. The approval indicates a labelin…

• FDA label_change · 2022-09-29
  FDA Approved: VAGIFEM — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for Vagifem (estradiol) from Novo Nordisk to update the product labeling.

• FDA label_change · 2018-10-26
  FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)

  FDA approved a supplemental application for OSPHENA (ospemifene) by Duchesnay USA, Inc., typically to modify labeling.

• FDA label_change · 2017-11-01
  FDA Approved: VAGIFEM — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for Vagifem (estradiol) by Novo Nordisk, resulting in changes to the labeling of this vaginal estrog…

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• FDA label_change · 2017-03-01
  FDA Approved: VAGIFEM — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for Vagifem (estradiol) by Novo Nordisk. This action updates the product labeling for the vagina…

• FDA label_change · 2010-01-13
  FDA Approved: PREMARIN VAGINAL — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for PREMARIN VAGINAL (conjugated estrogens) to update its labeling.