Vaginal Atrophy

• FDA approval · 2026-02-12
  FDA Approved: ESTRING — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approves Pfizer's Supplemental Application for ESTRING (estradiol vaginal ring), updating labeling for the product.

• FDA approval · 2025-05-19
  FDA Approved: ESTRADIOL VAGINAL CREAM — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Prasco Laboratories' generic estradiol vaginal cream.

• FDA approval · 2024-08-02
  FDA Approved: ESTRADIOL VAGINAL INSERTS — Original Application (NorthStar Rx LLC)

  FDA approved NorthStar Rx LLC's estradiol vaginal inserts via an original application (ANDA) as a generic estrogen therapy for postmenopausa…

• FDA approval · 2024-02-15
  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/Pfizer, updating labeling for the product.

• FDA approval · 2024-02-15
  FDA Approved: ESTRING — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for ESTRING (estradiol) from Pfizer Laboratories, updating labeling for the product.

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• FDA approval · 2024-01-29
  FDA Approved: ESTRADIOL VAGINAL — Supplemental Application (Encube Ethicals, Inc.)

  The FDA approved a supplemental application for Estradiol Vaginal (ESTRADIOL) from Encube Ethicals, Inc., updating the labeling/approval sta…

• FDA approval · 2019-04-09
  FDA Approved: VAGIFEM — Supplemental Application (Novo Nordisk)

  FDA has approved a supplemental application for Vagifem (estradiol) filed by Novo Nordisk.

• FDA approval · 2016-11-16
  FDA Approved: INTRAROSA — Original Application (Millicent US, Inc.)

  FDA approved INTRAROSA (prasterone) from Millicent US, Inc. as an Original Application (NDA 208470) for the treatment of dyspareunia due to …

• FDA approval · 2014-09-25
  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 modify the pr…

• FDA approval · 2014-05-16
  FDA Approved: ESTRING — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA granted a supplemental approval for ESTRING (estradiol) from Pfizer, updating the product's labeling/indication.

• FDA approval · 2012-04-11
  FDA Approved: PREMARIN — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for Premarin (conjugated estrogens) filed by Wyeth Pharmaceuticals, a Pfizer subsidiary. The submiss…

• FDA approval · 2011-04-22
  FDA Approved: PREMARIN VAGINAL — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

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

• FDA approval · 2008-08-25
  FDA Approved: ESTRING — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for ESTRING (estradiol) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2008-03-03
  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) submitted by Wyeth Pharmaceuticals (Pfizer). This ac…

• FDA approval · 2007-02-14
  FDA Approved: FEMRING — Supplemental Application (Millicent US, Inc.)

  FDA approved a supplemental application for FEMRING (estradiol acetate) from Millicent US, Inc., updating/expanding the product's labeling p…