Vulvar and Vaginal Atrophy Due to Menopause

• FDA approval · 2025-10-15
  FDA Approved: ESTROGENS, CONJUGATED — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved a generic version of conjugated estrogens under an original ANDA from Ingenus Pharmaceuticals.

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

  The FDA approved a supplemental application for Prempro (conjugated estrogens and medroxyprogesterone acetate) submitted by Wyeth/Pfizer to …

• FDA label_change · 2024-02-15
  FDA Approved: VAGIFEM — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for VAGIFEM (estradiol) from Novo Nordisk, resulting in updated labeling for the product.

• FDA approval · 2024-02-15
  FDA Approved: IMVEXXY — Supplemental Application (Mayne Pharma LLC)

  The FDA approved a supplemental application for IMVEXXY (estradiol) submitted by Mayne Pharma LLC.

• FDA approval · 2023-08-18
  FDA Approved: FEMRING — Supplemental Application (Millicent US, Inc.)

  The FDA approved a supplemental application for FemRing (estradiol acetate vaginal ring) from Millicent US, Inc.

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• FDA approval · 2021-02-17
  FDA Approved: ESTRADIOL VAGINAL INSERTS — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's supplemental application for Estradiol Vaginal Inserts (estradiol).

• FDA approval · 2019-01-25
  FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)

  The FDA approved a supplemental application for Osphena (ospemifene) from Duchesnay USA, Inc., likely updating its indications or labeling.

• FDA approval · 2018-08-09
  FDA Approved: ESTRADIOL VAGINAL — Supplemental Application (AvKARE)

  FDA approved a supplemental application for Estradiol Vaginal (Estradiol) from AvKARE, granting approval of the generic vaginal estrogen pro…

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

  The FDA approved a supplemental application for Premarin Vaginal (conjugated estrogens) from Wyeth Pharmaceuticals (Pfizer) to update labeli…

• 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…

• FDA approval · 2014-01-08
  FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)

  FDA approved a supplemental application for Osphena (ospemifene) submitted by Duchesnay USA, Inc.

• FDA label_change · 2012-02-14
  FDA Approved: PREMARIN VAGINAL — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application for Premarin Vaginal (conjugated estrogens), resulting in a labeling update.

• FDA approval · 2008-11-07
  FDA Approved: PREMARIN VAGINAL — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for Premarin Vaginal (conjugated estrogens) from Wyeth Pharmaceuticals (Pfizer) for updated labeling…

• FDA approval · 2008-10-30
  FDA Approved: EVAMIST — Supplemental Application (Padagis US LLC)

  The FDA approved a supplemental application for EVAMIST, a transdermal estradiol product, under Padagis US LLC.