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  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.025MG/24HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.0375MG/24HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.06MG/24HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.075MG/24HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.1MG/24HR
  • INSERT, EXTENDED RELEASE;VAGINAL - 0.0075MG/24HR
  • SYSTEM;TRANSDERMAL - 0.025MG/24HR
  • SYSTEM;TRANSDERMAL - 0.0375MG/24HR
  • SYSTEM;TRANSDERMAL - 0.05MG/24HR
  • SYSTEM;TRANSDERMAL - 0.075MG/24HR
  • SYSTEM;TRANSDERMAL - 0.1MG/24HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR
  • TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 1MG;0.5MG
  • TABLET;VAGINAL - 10MCG
  • TABLET;VAGINAL - 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • CAPSULE;ORAL - 0.5MG;100MG
  • CAPSULE;ORAL - 1MG;100MG
  • GEL, METERED;TRANSDERMAL - 0.06% (1.25GM/ACTIVATION)
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.045MG/24HR;0.015MG/24HR
  • TABLET;ORAL - 0.25MG;0.5MG
  • TABLET;ORAL - 0.5MG;1MG
  • GEL, METERED;TRANSDERMAL - 0.06% (0.87GM/ACTIVATION)
  • SPRAY;TRANSDERMAL - 1.53MG/SPRAY
  • GEL;TRANSDERMAL - 0.1%
  • CREAM;VAGINAL - 0.01%

https://www.cnbctv18.com/healthcare/zydus-lifesciences-gets-final-approval-from-the-us-fda-to-market-estradiol-transdermal-system-16431761.htm

CNBCTV18
19 Apr 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-22-2023-25079.pdf

FDA
22 Mar 2023

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-litigation-for-elagolix-sodium-estradiol-norethindrone-acetate-capsules-71055.pdf

FDA
08 Mar 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206241

FDA
01 Dec 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211783

FDA
10 Aug 2022

https://www.fiercepharma.com/pharma/myovant-pfizers-myfembree-wins-fda-nod-endometriosis

Zoey Becker FIERCEPHARMA
09 Aug 2022

https://www.fiercepharma.com/pharma/pfizer-myovants-myfembree-back-track-endometriosis-nod-aug-execs-say

Fraiser Kansteiner FIERCEPHARMA
30 Jul 2022

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fagron-group-bv-624255-06142022

FDA
29 Jun 2022

https://www.pharmatimes.com/news/nice_draft_final_guidance_for_gedeon_richter_uks_new_uterine_fibroids_treatment_1448342

Ana Ovey PHARMATIMES
13 May 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-9-2022-1644385243.pdf

FDA
09 Feb 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-17-2021-1637135168.pdf

FDA
17 Nov 2021

http://www.pharmafile.com/news/588612/theramex-pioneers-new-treatment-post-menopausal-women

PHARMAFILE
24 Sep 2021

https://www.businesswire.com/news/home/20210921006102/fr

BUSINESSWIRE
21 Sep 2021

https://www.prnewswire.com/news-releases/avion-pharmaceuticals-recognizes-menopause-awareness-month-by-announcing-the-addition-of-divigel-estradiol-gel-0-1-to-their-product-portfolio-301379678.html

PRNEWSWIRE
20 Sep 2021

https://www.globenewswire.com/news-release/2021/09/09/2294109/0/en/Myovant-Sciences-and-Pfizer-Announce-FDA-Acceptance-of-Supplemental-New-Drug-Application-for-MYFEMBREE-for-the-Management-of-Moderate-to-Severe-Pain-Associated-With-Endometriosis.html

GLOBENEWSWIRE
09 Sep 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-25-2021-1629867988.pdf

FDA
25 Aug 2021

https://www.ema.europa.eu/en/documents/overview/ryeqo-epar-medicine-overview_en.pdf

EMA
29 Jul 2021

https://www.globenewswire.com/news-release/2021/06/28/2253818/30757/en/Dar%C3%A9-Bioscience-Announces-Positive-Phase-1-Results-for-DARE-HRT1.html

GLOBENEWSWIRE
28 Jun 2021

https://www.businesswire.com/news/home/20200921005824/en

BUSINESSWIRE
21 Sep 2020

https://extranet.who.int/prequal/news/bayer-estradiolnorethisterone-injection-pre-filled-syringes-prequalified

WHO
18 Aug 2020

https://www.prnewswire.com/news-releases/sumitovant-biopharma-announces-publication-of-myovant-abstracts-detailing-additional-efficacy-and-safety-findings-from-phase-3-liberty-studies-in-uterine-fibroids-in-obstetrics--gynecology-301049697.html

PR NEWSWIRE
29 Apr 2020

https://www.prnewswire.com/news-releases/sumitovant-biopharma-reports-key-clinical-and-regulatory-milestones-by-myovant-sciences-301046868.html

PR NEWSWIRE
24 Apr 2020

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-april-22-2020-1587564893.pdf

FDA
22 Apr 2020

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-bijuva-nda-210132-estradiol-and-progesterone-4-mcg-and-10-mcg-1585974134.pdf

FDA
10 Mar 2020

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-imvexxy-208564-estradiol-4-mcg-and-10-mcg-1582965685.pdf

FDA
29 Feb 2020

https://www.ema.europa.eu/en/news/four-week-limit-use-high-strength-estradiol-creams

EMA
17 Jan 2020

https://www.businesswire.com/news/home/20191205005303/en

BUSINESSWIRE
05 Dec 2019

https://seekingalpha.com/news/3522041-health-canada-review-knights-nds-bijuva

M. Mayani SEEKING Alpha
28 Nov 2019

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/glenmark-recalls-over-2-lakh-cartons-of-product-in-us/articleshow/71991476.cms

THE ECONOMIC TIMES
12 Nov 2019

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-6-2019-1573017375.pdf

FDA
06 Nov 2019

https://www.businesswire.com/news/home/20191030005762/en/Knight-TherapeuticsMD-Announce-Filing-New-Drug-Submission/?feedref=JjAwJuNHiystnCoBq_hl-WBlLQO14j4QZPTyX5CYOnwC4VjN53jumZRlnzhBoBxGrCOi9QzgjCezTS3Nw_X6kJUrpSBm-Hav1w-UkdSlG3ltkRSnqzf6ourQGu_UA28CzZCGORvG0LE20YOvo49uqw==

BUSINESSWIRE
31 Oct 2019

https://www.ema.europa.eu/en/news/four-week-limit-use-high-strength-estradiol-creams

EMA
10 Oct 2019

https://www.ema.europa.eu/en/news/four-week-limit-use-high-strength-estradiol-creams

EMA
05 Oct 2019

https://en.prnasia.com/releases/global/mayne-pharma-signs-20-year-exclusive-license-and-supply-agreement-for-novel-oral-contraceptive-in-the-us-259662.shtml

PRNASIA
02 Oct 2019

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-7-2019-1565155577.pdf

FDA
07 Aug 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202318

FDA
27 Jul 2019

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-june-19-2019-1560925761.pdf

FDA
19 Jun 2019
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