Vulvar and Vaginal Atrophy

• EMA approval · 2024-11-25
  EMA Authorised: Senshio (ospemifene) — Shionogi B.V.

  The EMA authorised Senshio (ospemifene) for postmenopausal vulvar and vaginal atrophy. Marketing authorization was granted to Shionogi B.V. …

• FDA approval · 2024-08-02
  FDA Approved: LYLLANA — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for LYLLANA (estradiol) submitted by Amneal Pharmaceuticals LLC.

• FDA approval · 2024-02-16
  FDA Approved: ESTRADIOL VAGINAL — Supplemental Application (Encube Ethicals, Inc.)

  FDA approved a supplemental application for ESTRADIOL VAGINAL (Encube Ethicals, Inc.), updating labeling for the product under ANDA 209767.

• FDA approval · 2024-02-15
  FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)

  FDA approves a supplemental application for OSPHENA (ospemifene) submitted by Duchesnay USA, Inc.

• FDA approval · 2023-11-14
  FDA Approved: ESTRADIOL — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved an Estradiol generic product from Padagis Israel Pharmaceuticals Ltd under an Original Application, enabling its use for estrog…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2023-08-24
  FDA Approved: ESTRADIOL — Original Application (NorthStar Rx LLC)

  FDA approved NorthStar Rx LLC's Estradiol as an original-application generic product (ANDA217610).

• 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 · 2021-11-30
  FDA Approved: ESTROGEL — Supplemental Application (ASCEND Therapeutics US, LLC)

  FDA approved a supplemental application for ESTROGEL (estradiol) from ASCEND Therapeutics US, LLC, expanding the product's labeling for meno…

• FDA approval · 2019-02-05
  FDA Approved: DOTTI — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal's original application for DOTTI, a generic estradiol product, expanding availability of estrogen replacement therap…

• FDA approval · 2018-01-22
  FDA Approved: ESTRADIOL VAGINAL — Original Application (AvKARE)

  FDA approved AvKARE's Estradiol Vaginal as an Original Application (ANDA) for a generic estradiol vaginal product. It is indicated for the t…

• 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 · 2017-03-17
  FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)

  FDA approved a supplemental application for OSPHENA (ospemifene) filed by Duchesnay USA, Inc.

• FDA approval · 2015-08-24
  FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)

  FDA approved a supplemental application for OSPHENA (ospemifene) filed by Duchesnay USA, Inc.

• FDA approval · 2014-07-31
  FDA Approved: VIVELLE-DOT — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for VIVELLE-DOT (estradiol) from Sandoz Inc., updating the product labeling.

• 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 · 2012-11-09
  FDA Approved: VAGIFEM — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for Vagifem (estradiol) submitted by Novo Nordisk. The action typically relates to changes in labeli…

• FDA approval · 2011-10-28
  FDA Approved: CONJUGATED ESTROGENS — Supplemental Application (Prasco Laboratories)

  FDA has approved a supplemental NDA for Conjugated Estrogens (Estrogens, Conjugated) from Prasco Laboratories.

• FDA approval · 2011-05-17
  FDA Approved: VAGIFEM — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for Vagifem (estradiol) from Novo Nordisk, indicating updated labeling for the product.

• FDA approval · 2007-10-11
  FDA Approved: DELESTROGEN — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for Delestrogen (estradiol valerate) from Par Health USA, LLC, resulting in updated labeling for…

• FDA approval · 2006-12-15
  FDA Approved: ELESTRIN — Original Application (Viatris Specialty LLC)

  FDA approved ELESTRIN (estradiol) via an original NDA; indicates estrogen replacement therapy for menopausal symptoms and related indication…

• FDA approval · 2006-07-26
  FDA Approved: PREMARIN VAGINAL — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for Premarin Vaginal (conjugated estrogens) submitted by Wyeth Pharmaceuticals (a subsidiary of Pfiz…