Genitourinary Syndrome of Menopause

• 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 · 2025-02-07
  FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)

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

• 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 · 2024-04-22
  FDA Approved: ESTRADIOL — Original Application (Solaris Pharma Corporation)

  FDA approves Solaris Pharma Corporation's Estradiol as an original application (generic) product for estrogen replacement therapy.

• FDA approval · 2024-02-16
  FDA Approved: ESTRADIOL VAGINAL CREAM — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application from Prasco Laboratories for Estradiol vaginal cream, granting approval for the generic product.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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.

• 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 · 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 · 2022-07-27
  FDA Approved: ESTRING — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for ESTRING (estradiol vaginal ring) from Pfizer Laboratories Div Pfizer Inc. The approval updates t…

• FDA approval · 2019-11-21
  FDA Approved: IMVEXXY — Supplemental Application (Mayne Pharma LLC)

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

• 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 · 2018-09-14
  FDA Approved: ESTRADIOL VAGINAL INSERTS — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark’s estradiol vaginal inserts as a generic product (ANDA 210264) for the relief of symptoms of vaginal atrophy due to me…

• FDA approval · 2018-03-05
  FDA Approved: ESTRADIOL VAGINAL — Original Application (Encube Ethicals, Inc.)

  FDA approved Estradiol Vaginal from Encube Ethicals, Inc. as an Original Application under ANDA 209767.

• FDA approval · 2018-02-13
  FDA Approved: INTRAROSA — Supplemental Application (Millicent US, Inc.)

  The FDA approved a supplemental application for INTRAROSA (prasterone) by Millicent US, Inc., signaling regulatory approval of a supplementa…

• FDA approval · 2017-11-01
  FDA Approved: FEMRING — Supplemental Application (Millicent US, Inc.)

  The FDA approved a supplemental application for FEMRING (estradiol acetate) from Millicent US, Inc., indicating changes to the product's lab…

• 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 · 2015-05-29
  FDA Approved: YUVAFEM — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal's YUVAFEM, a generic estradiol product, under an Original Application (ANDA205256).

• FDA approval · 2015-04-20
  FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)

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

• FDA approval · 2015-02-25
  FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)

  The FDA approved a supplemental application for Osphena (ospemifene) from Duchesnay USA, Inc., confirming/expanding the labeling related to …

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

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

• FDA approval · 2013-09-27
  FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)

  The FDA approved a supplemental application for OSPHENA (ospemifene) submitted by Duchesnay USA, Inc. The exact changes to the labeling or i…

• FDA approval · 2013-02-26
  FDA Approved: OSPHENA — Original Application (Duchesnay USA, Inc.)

  FDA approved Osphena (ospemifene) from Duchesnay USA, Inc. under its original NDA for the treatment of dyspareunia due to menopause.

• FDA approval · 2012-04-11
  FDA Approved: VAGIFEM — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental NDA for VAGIFEM (estradiol) by Novo Nordisk, updating its label as part of a supplemental application.