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  • TABLET;ORAL-28 - 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A
  • INTRAUTERINE DEVICE;INTRAUTERINE - 52MG
  • TABLET;ORAL - 0.02MG;0.1MG
  • INTRAUTERINE DEVICE;INTRAUTERINE - 52MG
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.045MG/24HR;0.015MG/24HR
  • TABLET;ORAL - 1.5MG

https://www.fiercepharma.com/marketing/perrigo-pairs-opill-otc-birth-control-med-wnba-multi-year-team

FIERCE PHARMA
10 Apr 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217087

FDA
15 Feb 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214640

FDA
16 Aug 2023

https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive

FDA
14 Jul 2023

https://www.globenewswire.com/news-release/2023/06/26/2694408/30925/en/Agile-Therapeutics-Announces-the-Availability-of-Twirla-to-MMCAP-Infuse-Members.html

GLOBENEWSWIRE
26 Jun 2023

https://endpts.com/bayer-launches-seeing-red-campaign-to-break-taboos-around-heavy-periods-for-women/

Nicole DeFeudis ENDPTS
16 May 2023

https://www.fiercepharma.com/pharma/fda-will-hear-perrigos-otc-bid-birth-control-med-opill-may

Kevin Dunleavy FIERCE PHARMA
28 Mar 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212298

FDA
13 Feb 2023

https://www.prnewswire.com/news-releases/fda-approves-medicines360s-liletta-levonorgestrel-releasing-intrauterine-system-52-mg-to-prevent-pregnancy-for-up-to-eight-years-301676741.html

PRNEWSWIRE
14 Nov 2022

https://pharmaphorum.com/news/bayer-get-eu-nod-for-extended-use-of-contraceptive-mirena/

PHARMAPHORUM
14 Oct 2022

https://www.globenewswire.com/news-release/2022/10/07/2530548/30925/en/Agile-Therapeutics-Announces-Reorganization-of-Leadership-Team.html

GLOBENEWSWIRE
07 Oct 2022

https://endpts.com/bayer-gets-fda-nod-to-extend-use-of-popular-contraceptive-iud-mirena/

Nicole DeFeudis ENDPTS
19 Aug 2022

https://www.globenewswire.com/news-release/2022/01/10/2363993/30925/en/Agile-Therapeutics-and-Afaxys-Partner-to-Expand-Access-to-Twirla-Levonorgestrel-and-Ethinyl-Estradiol-Transdermal-System.html

GLOBENEWSWIRE
10 Jan 2022

http://www.pharmabiz.com/NewsDetails.aspx?aid=142132&sid=2

PHARMABIZ
27 Aug 2021

https://www.businesswire.com/news/home/20210825005784/en

BUSINESSWIRE
25 Aug 2021

https://www.globenewswire.com/news-release/2021/08/20/2284071/30925/en/Agile-Therapeutics-Partners-with-Telehealth-Service-Pandia-Health-to-Increase-Women-s-Access-to-Twirla-levonorgestrel-and-ethinyl-estradiol-transdermal-system.html

GLOBENEWSWIRE
20 Aug 2021

https://www.business-standard.com/article/news-cm/zydus-and-bayer-announce-continuity-of-their-successful-joint-venture-121062100484_1.html

BUSINESS-STANDARD
21 Jun 2021

https://www.globenewswire.com/news-release/2020/12/07/2140453/0/en/Agile-Therapeutics-Announces-Nationwide-Commercial-Launch-and-Availability-of-Twirla-levonorgestrel-and-ethinyl-estradiol-Transdermal-System-a-New-Non-Daily-Non-Invasive-Contracept.html

GLOBENEWSWIRE
07 Dec 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=091692

FDA
27 Oct 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207033

FDA
14 Oct 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207065

FDA
19 Aug 2020

https://www.globenewswire.com/news-release/2020/01/02/1965657/0/en/Agile-Therapeutics-Strengthens-Commercial-Leadership-Team.html

GLOBENEWSWIRE
02 Jan 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207660

FDA
06 May 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202988

FDA
07 Feb 2019

https://www.europeanpharmaceuticalreview.com/news/83166/fda-grant-generic-intravaginally-iud/

EURO PHARMA REVIEW
21 Jan 2019

https://www.ema.europa.eu/documents/psusa/levonorgestrel-list-nationally-authorised-medicinal-products-psusa/00001856/201712_en.pdf

EMA
12 Nov 2018

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-october-24-2018-1540357479.pdf

FDA
24 Oct 2018

https://www.prnewswire.com/news-releases/fda-approves-medicines360s-snda-for-liletta-levonorgestrel-releasing-intrauterine-system-52-mg-to-prevent-pregnancy-for-up-to-five-years-300731645.html

PR NEWSWIRE
16 Oct 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205329

FDA
21 Sep 2018

https://www.prnewswire.com/news-releases/medicines360-afaxys-partner-to-expand-public-health-access-to-liletta-levonorgestrel-releasing-intrauterine-system-52-mg-300707671.html

PR NEWSWIRE
06 Sep 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204044

FDA
06 Jul 2018

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-may-30-2018-1527659653.pdf

FDA
29 May 2018

https://endpts.com/agile-bristles-after-fdas-third-snub-promising-a-fight-for-its-contraceptive/

B. Meiling ENDPTS
18 May 2018

https://www.businesswire.com/news/home/20180508005478/en

BUSINESSWIRE
08 May 2018

https://www.prnewswire.com/news-releases/fda-acceptance-of-medicines360s-filing-for-supplemental-new-drug-application-for-liletta-levonorgestrel-releasing-intrauterine-system-52-mg-300602473.html?tc=eml_cleartime

23 Feb 2018

https://www.pharmacompass.com/pdf/news/apotex-inc-issues-recall-of-alysena-28-levonorgestrel-and-ethinyl-estradiol-tablets-1518496775.pdf

HEALTH CANADA
13 Feb 2018

http://www.pharmatimes.com/news/uk_launch_for_bayers_five-year_contraceptive_kyleena_1221191

Selina McKee PHARMA TIMES
09 Feb 2018

https://www.drugstorenews.com/pharmacy/fda-approves-avion-pharmaceuticals-balcoltra/

DRUGSTORENEWS
18 Jan 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208612

FDA
11 Jan 2018

https://www.reuters.com/article/us-agile-fda/fda-rejects-agiles-contraceptive-patch-shares-plunge-idUSKBN1EG1FO

Divya Grover REUTERS
23 Dec 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205131

FDA
17 Dec 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206053

FDA
04 Oct 2017

http://www.gmp-compliance.org/gmp-news/whos-position-on-the-import-alert-for-a-chinese-api-manufacturers-products

GMP
04 Jul 2017

https://www.pharmacompass.com/pdf/news/qinhuangdao-zizhu-pharmaceutical-co-ltd-on-who-public-inspection-report-1499234513.pdf

WHO
30 Jun 2017

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-june-14-2017-1497417449.pdf

FDA
14 Jun 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202875

FDA
08 May 2017

http://www.in-pharmatechnologist.com/Ingredients/US-ban-for-contraceptive-API-firm-Qinhuangdao-Zizhu-has-WHO-worried

G. MacDonald IN PHARMATECHNOLOGIST
20 Apr 2017

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-april-19-2017-1492575710.pdf

FDA
19 Apr 2017

http://www.fiercepharma.com/regulatory/fda-ban-chinese-company-leaves-who-scrambling-for-contraceptives

Eric Palmer FIERCE PHARMA
14 Apr 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206851

FDA
10 Apr 2017
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