Genitourinary Syndrome of Menopause
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Sign up freeTop drugs studied for this disease
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FDA label_change · 2018-10-26FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)
FDA approved a supplemental application for OSPHENA (ospemifene) by Duchesnay USA, Inc., typically to modify labeling.
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FDA approval · 2018-09-14FDA 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…
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CLINICAL_TRIALS trial_result · 2018-07-26Clinical Trial Update: GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors [EARLY_Phase 1]
An early Phase 1 trial evaluating genitourinary syndrome of menopause management in breast cancer survivors was terminated.
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FDA approval · 2018-03-05FDA Approved: ESTRADIOL VAGINAL — Original Application (Encube Ethicals, Inc.)
FDA approved Estradiol Vaginal from Encube Ethicals, Inc. as an Original Application under ANDA 209767.
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FDA approval · 2018-02-13FDA 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…
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FDA label_change · 2017-11-01FDA 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 approval · 2017-11-01FDA 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…
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FDA label_change · 2017-03-01FDA 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…
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FDA approval · 2016-11-16FDA 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 …
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CLINICAL_TRIALS trial_result · 2015-11-10Clinical Trial Update: Clinical Study for Perceived Effectiveness Evaluation of Moisturizing Action of Intimate Use Product in Postmenopausal Women [NA]
A completed clinical trial evaluating the perceived effectiveness of a moisturizing intimate-use product for postmenopausal women with dryne…
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FDA approval · 2015-05-29FDA Approved: YUVAFEM — Original Application (Amneal Pharmaceuticals LLC)
The FDA approved Amneal's YUVAFEM, a generic estradiol product, under an Original Application (ANDA205256).
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FDA approval · 2015-04-20FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)
FDA approved the supplemental application for Osphena (ospemifene) submitted by Duchesnay USA, Inc.
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FDA approval · 2015-02-25FDA 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 …
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CLINICAL_TRIALS trial_result · 2014-06-26Clinical Trial Update: Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo [Phase 3]
Phase 3 trial evaluating safety and bioequivalence of estradiol vaginal inserts (10 mcg) with Vagifem (10 mcg) and placebo for vaginal atrop…
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FDA approval · 2014-05-16FDA 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.
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FDA approval · 2014-03-11FDA Approved: EVAMIST — Supplemental Application (Padagis US LLC)
FDA approved a supplemental application for EVAMIST (estradiol) by Padagis US LLC.
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EMA guidance · 2013-12-20The European Medicines Agency recommends that estradiol-containing creams Linoladiol N and Linoladiol HN remain available
The EMA recommends that estradiol-containing creams Linoladiol N and Linoladiol HN remain available on the market.
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FDA approval · 2013-09-27FDA 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…
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FDA approval · 2013-02-26FDA 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.
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FDA approval · 2012-04-11FDA 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.
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FDA approval · 2011-05-17FDA Approved: VAGIFEM — Supplemental Application (Novo Nordisk)
The FDA approved a supplemental application for Vagifem (estradiol) from Novo Nordisk, indicating updated labeling for the product.
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FDA approval · 2011-04-22FDA 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…
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CLINICAL_TRIALS trial_result · 2011-04-07Clinical Trial Update: Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis [Phase 3]
Phase 3 clinical trial update examining endometrial safety of a low-dose Vagifem in postmenopausal women with atrophic vaginitis; results ha…
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FDA label_change · 2010-01-13FDA 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.
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FDA approval · 2009-11-25FDA Approved: VAGIFEM — Supplemental Application (Novo Nordisk)
FDA approved a supplemental application for Vagifem (estradiol) from Novo Nordisk. It involves changes to the product's labeling under the s…